Medical Device Reports (MDRs) Archives - Discussions in Infection Control

Mon. Jul 14th, 2025

Adverse Event Reports Food and Drug Administration Food Drug and Cosmetic Act Medical Device Reports (MDRs) Misbranded Devices Patient Notification Warning letters (FDA)

Hundreds of Thousands of Device Reports Were Submitted Late to FDA, a New Study Has Found, Raising Safety Questions

May 13, 2025 Lawrence F Muscarella PhD

Hundreds of thousands of reports from device manufacturers describing an adverse event during a recent 3-and-a-half-year period were submitted to FDA late, a March study has found, raising questions about…

Adverse Event Reports Candida auris Carbapenem-Resistant Enterobacteriaceae (CRE) Duodenoscopes Endoscope Reprocessing Escherichia coli Gastroscopes MAUDE Medical Device Reports (MDRs) Risk Assessment Single-Use Disposable Devices

Gastroscopes Have Been Linked to a Cluster of Resistant E. coli Infections — Is the Risk Sufficiently Recognized?

January 6, 2023 Lawrence F Muscarella PhD

This article presents an FDA report filed in November (2022) — publicized now for the first time — that links gastroscopes to 3 patients testing positive for a “rare strain”…

Adverse Event Reports Colonoscopes Duodenoscopes Endoscope Reprocessing Food and Drug Administration Gastroscopes GI Endoscopes MAUDE Medical Device Reports (MDRs) Risk Assessment Single-Use Disposable Devices

Assessment of the Effectiveness of Today’s Endoscope Reprocessing Practices: An Abstract Updated guidance is provided to prevent multidrug-resistant bacterial infections.

September 27, 2022 Lawrence F Muscarella PhD

This review analyzed more than 10,000 medical device reports submitted to FDA since 2014 describing the contamination of a flexible endoscope.

You missed

Adverse Event Reports Food and Drug Administration Food Drug and Cosmetic Act Medical Device Reports (MDRs) Misbranded Devices Patient Notification Warning letters (FDA)

Hundreds of Thousands of Device Reports Were Submitted Late to FDA, a New Study Has Found, Raising Safety Questions

Gastroscopes Have Been Linked to a Cluster of Resistant E. coli Infections — Is the Risk Sufficiently Recognized?

Assessment of the Effectiveness of Today’s Endoscope Reprocessing Practices: An Abstract Updated guidance is provided to prevent multidrug-resistant bacterial infections.

You missed

Hundreds of Thousands of Device Reports Were Submitted Late to FDA, a New Study Has Found, Raising Safety Questions

Endoscopy Patients at Vanderbilt Potentially Exposed to HIV and Hepatitis, County Officials Have Confirmed

Dr. Muscarella’s Recent Recommendations to Medicare to Prevent Hospital-Acquired Infections

15 Patients Infected with Mycobacteria After Undergoing Cosmetic Surgery at a South Florida Clinic

Category: Medical Device Reports (MDRs)

Hundreds of Thousands of Device Reports Were Submitted Late to FDA, a New Study Has Found, Raising Safety Questions

Gastroscopes Have Been Linked to a Cluster of Resistant E. coli Infections — Is the Risk Sufficiently Recognized?

Assessment of the Effectiveness of Today’s Endoscope Reprocessing Practices: An Abstract Updated guidance is provided to prevent multidrug-resistant bacterial infections.

You missed

Hundreds of Thousands of Device Reports Were Submitted Late to FDA, a New Study Has Found, Raising Safety Questions

Endoscopy Patients at Vanderbilt Potentially Exposed to HIV and Hepatitis, County Officials Have Confirmed

Dr. Muscarella’s Recent Recommendations to Medicare to Prevent Hospital-Acquired Infections

15 Patients Infected with Mycobacteria After Undergoing Cosmetic Surgery at a South Florida Clinic