CONVERTORS 9011 (UDI 10885380156489)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885380156489), received between Mar 25, 2020 and Mar 25, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryMar 25, 2020Patient-Device Incompatibility

  THE CUSTOMER REPORTED THAT THE PHYSICIAN IS BREAKING OUT IN HIVES CAUSING OPEN LESIONS ON THE ARMS FROM THE AAMI 4 SMARTSLEEVE SURGICAL GOWN 9011. SHE WAS TREATED IN THE EMERGENCY ROOM WITH IV STEROIDS AND MEDROL DOSE PACK. ALLERGY TESTING WAS PERFORMED AND SHOWED THE PHYSICIAN IS ALLERGIC TO QUARTERNIUM 15. PHYSICIAN IS NO LONGER WEARING GOWN 9011 AND HIVES HAVE RESOLVED. NO OTHER INFORMATION WAS PROVIDED. THE ACTUAL EVENT DATE WAS UNKNOWN AFTER MULTIPLE ATTEMPTS TO CONTACT CUSTOMER.

  Patient problems: Urticaria

  MAUDE report 9881242 ↗