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Medical Device Reporting (MDR): How to Report Medical …
- https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
- Patients, healthcare professionals and consumers who find a problem related to a medical device are encouraged to report medical device adverse events or product problems to the FDA through...
Seven serious medical device failures that have led to urgent …
- https://www.nsmedicaldevices.com/analysis/medical-device-failures-fda-recalls/
Defective Drugs & Medical Devices
- https://www.consumernotice.org/drugs-and-devices/
- Medical device failures can lead to serious health problems. Implantable devices, such as knee replacements or defibrillators, often require surgery to remove or replace faulty …
Medical Device Recalls | FDA
- https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
- Summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could …
Medical Devices: Classification and Analysis of Faults …
- https://pubmed.ncbi.nlm.nih.gov/31691257/
- Conclusion: We defined a medical device fault as an unintended failure in the design, manufacture, or use of a medical device that leads to, or has the potential to lead to, …
Drug Side Effects & Medical Device Complications
- https://www.drugwatch.com/side-effects/
- Other common effects include drowsiness, pain and skin reactions. Minor complications from medical devices could include varying levels of pain. Common minor side effects …
Medical Equipment Failures - IAFC
- https://www.iafc.org/iCHIEFS/iCHIEFS-article/medical-equipment-failures
- In 2016, several patients with implanted cardioverter defibrillators (ICDs) experienced sudden, unexpected battery failure of their devices. Two patients died after …
Medical Device Makers Report …
- https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/
- But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA, many implanted in patients or used in countless surgeries. …
Medical device failures and adverse effects - LWW
- https://journals.lww.com/pec-online/Citation/1991/04000/Medical_device_failures_and_adverse_effects.15.aspx
- Medical device failures and adverse effects : Pediatric Emergency Care Previous Abstract Next Abstract Log in to view full text. If you're not a subscriber, you can: Buy Article …
Adverse events associated with the Inspire implantable …
- https://pubmed.ncbi.nlm.nih.gov/32645535/
- From these included reports, event variables were collected, including event setting, adverse event to patient, iatrogenic injury, device malfunction, interventions, and root causes. …
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