CONVERTORS 39049Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885380108693), received between Jun 19, 2018 and Mar 26, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2020Material Puncture/Hole; Failure to Align

  THE PHYSICIAN'S GOWN WAS NOTED TO BE MISALIGNED AT THE SEAMS CREATING HOLES IN THE STERILE GOWN. OPERATION ROOM TEAM MEMBERS COVERED IT WITH A TEGADERM AND KEPT WORKING. THE INTEGRITY OF PAPER GOWNS IS BEING CALLED INTO QUESTION WITH MULTIPLE ISSUES AND RECALLS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9882725 ↗
• InjuryJul 9, 2018Device Contamination with Body Fluid

  WHILE DOING AN APPENDECTOMY, A MALE RESIDENT HAD FLUID GO THROUGH, AND HIS ARM AND HAND WERE STAINED WITH BLOOD. THE RESIDENT HAD AN HIV TEST DONE, AND IT WAS NEGATIVE. THE RESIDENT LEFT THE HOSPITAL, SO THERE IS NO ADDITIONAL INFORMATION ABOUT HIM (NO AGE, WEIGHT ETC).

  Patient problems: Exposure to Body Fluids

  MAUDE report 7670821 ↗
• InjuryJun 19, 2018Insufficient Device Problem Information

  A RESIDENT GOT BLOOD ON HIS ARM AND DOWN TO HIS HAND WHILE DOING AN ABDOMINAL SURGERY. APPARENTLY THERE WAS NO HOLE ON THE SLEEVE. SINCE THE RESIDENT HAD A BLISTER ON ONE FINGER, (B)(6) AND (B)(6) TESTING WAS DONE ON THE PATIENT.

  Patient problems: Exposure to Body Fluids

  MAUDE report 7613986 ↗