Ioban™ 2 6648Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30707387444397), received between Feb 13, 2019 and Oct 26, 2020 — classified as 3 injuries.

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

• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SKIN STRIPPING OF THE EPIDERMIS AND DISCOMFORT UPON REMOVAL OF THE DRAPE WAS REPORTED FOR A PATIENT IN (B)(6) WHO UNDERWENT AN EIGHT-HOUR BYPASS SURGERY ON AN AREA UNDERNEATH A 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE 6648 THAT HAD BEEN PLACED. NO SKIN PREPARATION PRODUCTS HAD BEEN APPLIED AN PRIOR TO APPLICATION OF THE DRAPE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort

  MAUDE report 10737680 ↗
• InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL EMPLOYEE IN (B)(6) REPORTED THAT 6648 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPES WERE APPLIED TO A PATIENT FOR LEFT HIP REPLACEMENT SURGERY. CHLORHEXIDINE WAS USED FOR SKIN PREPARATION. A CIRCULAR SUPERFICIAL SKIN INJURY APPROXIMATELY 1CM FROM THE SURGICAL INCISION SITE ABOUT 5CM IN DIAMETER OCCURRED WHEN THE IOBAN DRAPE WAS REMOVED. THE SKIN WAS CLEANED WITH SODIUM CHLORIDE AND A MEDIPORE¿ + PAD SOFT CLOTH ADHESIVE WOUND DRESSING WAS APPLIED. THERE WAS NO SIGN OF INFECTION UPON HOSPITAL DISCHARGE. THE PATIENT LATER SAW A GENERAL PRACTITIONER WHO PRESCRIBED A 7-DAY COURSE OF ANTIBIOTIC FOR A SUSPECTED INFECTION.

  Patient problems: Injury; Pain

  MAUDE report 8829127 ↗
• InjuryFeb 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL EMPLOYEE IN (B)(6) REPORTED 6648 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPES WERE APPLIED TO A PATIENT FOR CARDIAC SURGERY. THE DRAPES WERE REPORTEDLY APPLIED TO INTACT SKIN. ALCOHOLIC CHLORHEXIDINE WAS USED FOR SKIN PREPARATION. A CIRCULAR SKIN INJURY IN THE THORACIC/LEFT BREAST AREA REPORTEDLY OCCURRED WHEN THE DRAPE WAS REMOVED. (B)(6) GAUZE AND A GAUZE DRESSING WERE APPLIED TO THE SITE AND SECURED WITH TAPE. DERMAZINE (SULFADIAZINE SILVER) WAS ALSO REPORTEDLY USED FOR TREATMENT.

  Patient problems: Injury

  MAUDE report 8335697 ↗