Ioban™ 2 6650Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30707387444403), received between Jan 25, 2021 and Dec 31, 2022 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  A FEMALE PATIENT WAS PREPPED WITH CHLORAPREP¿ FOR A 1ST RIB SURGICAL RESECTION AND 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE, 6650 WAS APPLIED AS PART OF THE STERILE DRAPE. POSTOPERATIVELY, THE PATIENT ALLEGEDLY EXPERIENCED A BURNING SENSATION TO THE LEFT NECK/CLAVICULAR SURGICAL SITE, AND THE 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE, 6650 REPORTEDLY REMAINED INTACT. APPROXIMATELY 12 HOURS POSTOPERATIVE, THE SURGICAL SITE WAS ASSESSED AND ERYTHEMA WITH BLISTERING AT THE SURGICAL SITE WERE OBSERVED. THE SURGICAL SITE HAS HEALED, HOWEVER, THE AREAS RESULTED IN SIGNIFICANT KELOID SCARRING, WITH TWO SCARS, ONE APPROXIMATELY 5 CM AND ONE APPROXIMATELY 7CM. THE PATIENT IS UNDER THE CARE OF A PLASTIC SURGEON WHO PLANS TO PERFORM RECONSTRUCTIVE SURGERY TO REVISE THE SCARS IN 2023.

  Patient problems: Blister

  MAUDE report 16081283 ↗
• InjurySep 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER ALLEGED A 15CM SKIN TEAR WITH THE USE OF A 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE AFTER SURGERY. NO MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION.

  Patient problems: Skin Tears

  MAUDE report 15337483 ↗
• InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED FROM (B)(6): A PATIENT THAT WAS DIAGNOSED WITH LIVER FAILURE UNDERWENT A LIVER TRANSPLANT SURGERY AND DEVELOPED SKIN STRIPPING AND SKIN TEARS. A 3M IOBAN 2 ANTIMICROBIAL INCISE DRAPE, CATALOG 6650, WAS APPLIED ON THE LEFT SIDE OF THE ABDOMEN AFTER SURGICAL SITE PREPARATION THAT CONSISTED OF SHAVING AND APPLICATION OF 10% POVIDONE IODINE FOLLOWED BY ALCOHOL FOR THREE TIMES. AFTER TWELVE HOURS OF DRAPE WEAR, THREE SKIN PEELS/EPIDERMAL LOSS/POSSIBLE MARSI WERE OBSERVED NEAR THE INCISION SITE, DESCRIBED AS TWO SMALL SKIN TEARS WERE OBSERVED OVER UPPER LEFT QUADRANT OF THE ABDOMEN (2CM X 2CM) AND ONE IN THE LOWER LEFT QUADRANT (3CMX3CM) THAT WERE OBSERVED NEAR THE DRAPE EDGES AND SUTURE SITES. THE SKIN WAS REPORTED AS DRY PRIOR TO DRAPE APPLICATION. NO MEDICAL TREATMENT WAS PROVIDED FOR THE SYMPTOMS; THE AREA WAS COVERED WITH ROUTINE POST-OPERATIVE DRESSINGS PER PROTOCOL. THE PATIENT IS IN THE ICU POST-LIVER TRANSPLANT SURGERY. SKIN INJURY POST-INCIDENCE WAS NOT OBSERVED.

  Patient problems: Skin Tears

  MAUDE report 12425454 ↗
• InjuryJan 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED FROM CHINA: A PATIENT HAD CARDIAC BYPASS SURGERY WITH VALVE REPLACEMENT AND ABLATION DEVELOPED SKIN REDNESS (3X5CM) SWELLING (10X12CM), BLISTERS AND A SKIN TEAR ON BOTH SIDES OF THE INCISION AFTER REMOVAL OF A 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE, CATALOG 6650 NEAR THE INCISION ALONG THE MID-STERNUM LINE TO THE NECK. SKIN PREPARATION INCLUDED APPLICATION OF AN IODOPHOR PREPARATION THAT COVERED A LARGER AREA THAN THE DRAPE. THE DRAPE WAS IN PLACE FOR APPROXIMATELY FIVE HOURS. OTHER DEVICES USED INCLUDED A NEGATIVE PLATE PLACED ON THE THIGH, ELECTRODES PLACED OUTSIDE THE SKIN AREA, AND AN INCISION SPREADER. A SECOND CASE WAS REPORTED FOR A CARDIAC SURGERY WHERE AN INCISION SPREADER WAS ALSO USED; CASE SPECIFIC INFORMATION WAS NOT PROVIDED. THE SKIN RECOVERED FOR BOTH PATIENTS.

  Patient problems: Blister; Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 11223751 ↗