MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-05 for
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Number of Events Reported 1 Summary Report (Y/N) N Report Source Manufacturer Source Type company representative,foreig Reporter Occupation Physician Type of Report Initial Report Date 09/16/2019 1 Device was Involved
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Event Date 06/14/2020. Event Type malfunction. Event Description. Patient called on behalf of her husband with a complaint involving hearing aids she ordered from audien hearing which they still have not received.Patient stated that her and her husband tried calling numbers they were given when they placed the order, but nobody picks up.Patient
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· Number of Events Reported 1 Summary Report (Y/N) N Report Source Manufacturer Source Type company representative,health Reporter Occupation Physician Type of Report Initial Report Date 02/03/2021 1 Device was Involved in the Event 1 Patient was Involved in the Event
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· In (b) (6) 2023, si-bone reviewed clinical study adverse events and made the decision to report this adverse event although it is unknown if the implants were the cause of the adverse event.The patient had spine fusion along with the installation of ifuse implants in (b) (6) 2021.Approximately 45 days post-op, the patient presented with sacral
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:Medical DevicesFDA MAUDEMAUDE data represents reports of adverse events involving medical devices. Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected
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Description of the MAUDE Database. The Manufacturer and User Facility Device Experience (MAUDE) database contains medical device reports (MDRs) of adverse
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· MAUDE Adverse Event Report: MRI. My father had an mri of the spine ordered at (b) (6) center.He has a history of a craniotomy for aneurysm clipping in 1982, and should not have an mri due to the risk of migration of clips and possible bleeding.Md well aware of his history, and ordered mri anyway.During the mri, my father became
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· 10-year overview of >10 million Medical Device Reports in MAUDE. • Analysis by clinical category, device and patient problems, and adverse events. • ∼90% of MDR’s related to medical device function, 8% to coded adverse events. • Sex-based differences were
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Number of Events Reported 1 Summary Report (Y/N) N Report Source Manufacturer Source Type company representative,health Reporter Occupation Physician Type of Report Initial Report Date 11/23/2020 1 Device was Involved
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:Maude Medical Device Adverse EventsThe MAUDE DatabaseFda Maude DatabaseIt also summarizes adverse events to patients (AEPs) and device malfunctions (DMs) reported in the MAUDE database, and attempts to examine the consequences brought
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MAUDE Adverse Event Report: ACESSA HEALTH INC. ACESSA PROVU HANDPIECE. ACESSA HEALTH INC. ACESSA PROVU HANDPIECE. Identified during a physician's round table discussion that occurred after the procedure, was reported by an acessa rep attendee that heard the discussion.Physician indicated that the patient was fine post-op,
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:Maude Medical Device Adverse EventsThe MAUDE DatabaseThe most frequently reported adverse events were unexpected robotic arm movement for TKA (59/204, 28.9%) and retained registration checkpoint for THA (19/44, 43.2%). There
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Report Number 3006443171-2019-00002 MDR Report Key 8746538 Date Received 2019-06-28 Date of Report 2019-06-28 Date of Event 2019-05-28 Date Mfgr Received 2019-05-30 Date Added to Maude 2019-06-28 Event Key 0 Report Source Code Manufacturer
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· Material and Methods: An analysis of MAUDE data was performed to examine the outcomes and device characteristics of adverse event reports from 1991 up to 11/2022. These outcomes included the event type, remedial action, report source, reporter occupation and device evaluation by manufacturer. Specific MD groups were analyzed
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· MDR Report Key 18041103 Report Number COR23000209-000 Device Sequence Number 1 Product Code JAA Reporter Country Code US Number of Events Reported 1 Summary Report (Y/N) N Report Source Manufacturer Reporter Occupation Other Type of Report
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Model Number BT-500. Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 07/01/2023. Event Type malfunction. Event Description. Bistos infant incubators got cracks in the body just after 2 years of installation. Search Alerts/Recalls. 22. New Search | Submit an Adverse Event Report.
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· The MAUDE database contains adverse event reports that involve end user interactions with medical devices (also known as medical device reports). These adverse events describe suspected device-associated deaths, serious injuries, and malfunctions, with a wide range of causes (e.g., from manufacturing to usability issues).
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:MAUDEAdverse Event Report · 10-year overview of >10 million Medical Device Reports in MAUDE. • Analysis by clinical category, device and patient problems, and adverse events. • ∼90%
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Number of Events Reported 1 Summary Report (Y/N) N Report Source Manufacturer Source Type Health Professional,User Facility,Company Representative Reporter Occupation Other Health Care Professional Type of Report Initial Report Date 08/05/2014,07/11
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Event Description It was reported that a peritoneal dialysis (pd) patient required their pd catheter to be removed.The patient was sent to the emergency room on (b)(6) 2023 for pd catheter removal and to have a central venous catheter (cvc) placed.File#: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
ConsultaThis event is being reported as a malfunction of the keller funnel device because it may have contributed to the delamination of the breast implant shell.Although there was no
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Number of Events Reported 1 Summary Report (Y/N) N Report Source Manufacturer Source Type Health Professional,Company Representative Reporter Occupation Other Health Care Professional Type of Report Initial,Followup Report Date 01/05/2022 1 Device was Involved in the Event
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Number of Events Reported 1 Summary Report (Y/N) N Report Source Manufacturer Source Type company representative,health Reporter Occupation Physician Type of Report Initial Report Date 06/21/2018 1 Device was Involved
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MDR Report Key 13543755 MDR Text Key 285771957 Report Number MW5107504 Device Sequence Number 1 Product Code OZP Combination Product (y/n) N Reporter Country Code US Number of Events Reported 1 Summary Report (Y/N) N Report Source
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MAUDE Adverse Event Report MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-01-14 for * manufactured by Medx 96 Inc.. Report Number 1051095-1999-00002 MDR
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for each adverse event. Continuous variables underwent analysis using a two-tailed student test, and signicance was set t to p ≤ 0.05. Results During the study period, 548 MAUDE reports revealed 873 device failures and 186 patient-related adverse events.
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The report was created to capture the events of death reported in the article: mourand et al.Diffusion-weighted imaging score of the brain stem: a predictor of outcome in acute basilar artery occlusion treated with solitaire fr device.Am j neuroradiol.35:1117-23 jun
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Number of Events Reported 1 Summary Report (Y/N) N Report Source Manufacturer Source Type company representative Type of Report Initial,Followup Report Date 08/28/2020 1 Device was Involved in the Event 1 Patient
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Event Date 06/16/2022. Event Type Injury. Event Description. A (b) (6) male presented to the emergency department with right leg swelling and pain.Ultrasound confirmed deep vein thrombosis (dvt) of the right common femoral, right popliteal, and right deep femoral veins.The clot was chronic (aged approximately 30 days) and the patient had been
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Trituradora de piedra vendida por proveedores certificados, como trituradoras de mandíbula/cono/impacto/móvil, etc.
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