Ioban™ 2 6635Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30707387444373), received between Jul 21, 2020 and Jul 21, 2020 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 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.

• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL PHARMACIST IN (B)(6) REPORTED THAT A 6635 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE WAS APPLIED TO A FEMALE PATIENT FOR SURGERY ON (B)(6) 2020 (TYPE OF SURGERY UNSPECIFIED). SUBCUTANEOUS BLEEDING OF THE FRONT OF THE NECK AND UPPER CHEST IN THE AREAS OF INCISION WAS OBSERVED. OTHER SYMPTOMS INCLUDED REDNESS, SWELLING, AND BLISTERS UNDER THE AREA WHERE THE DRAPE WAS PLACED, ALONG WITH RASH, SKIN STRIPPING, SKIN TEARING AND MACERATION. THE SIZE OF THE RASH WAS 4X5CM AND OCCURRED IMMEDIATELY POST-OPERATIVE. THE DRAPE WAS IN PLACE FOR APPROXIMATELY TWO HOURS BEFORE THE SYMPTOMS BEGAN, NO MEDICAL TREATMENT WAS REQUIRED FOR THE SYMPTOMS, AND THE RASH DECREASED OVER SEVERAL DAYS. DISINFECTANTS (NOT SPECIFIED) WERE USED PRIOR TO PLACEMENT OF THE DRAPE. THE SKIN WAS REPORTED TO BE DRY PRIOR TO APPLICATION OF THE DRAPE.

  Patient problems: Erythema; Hemorrhage/Blood Loss/Bleeding; Skin Tears; Swelling

  MAUDE report 10303604 ↗