CONVERTORS 89015NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 50885380003804), received between Apr 20, 2017 and Apr 20, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2017Insufficient Device Problem Information

  FEMALE CERTIFIED SURGICAL TECHNICIAN (CST) APPARENTLY REPORTED THAT SHE HAD HIVES ON HER HANDS AND WRISTS WHEN SHE TOOK OFF THE GOWN AND GLOVES. POSSIBLE DISCOMFORT ALSO AT NECK AREA WHERE GOWN CONTACTS THE SKIN. HER WRISTS BECAME SWOLLEN THE NEXT DAY AND SHE WENT TO A PHYSICIAN. SHE WAS PUT ON STEROIDS AND H2 BLOCKERS TO HELP WITH THE REACTION. NO OTHER INFORMATION ABOUT THE CERTIFIED SURGICAL TECHNICIAN CST (AGE, WEIGHT, ALLERGY HISTORY) OR ABOUT THE EVENT WERE PROVIDED.

  Patient problems: Swelling; Urticaria

  MAUDE report 6508117 ↗