Ioban™ 2 6640EZSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 50707387559354), received between Mar 22, 2018 and Mar 23, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryMar 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICIANS REPORTED A PATIENT EXPERIENCED REDNESS, BLISTERING AND SKIN PIGMENT REMOVAL WHEN A 6640EZ 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE WAS REMOVED FOLLOWING A SPINAL PROCEDURE. THE PATIENT INITIALLY EXPERIENCED A 2" X 2" AREA OF SKIN PIGMENT REMOVAL AND BLISTERING WHEN THE DRAPE WAS REMOVED NEAR THE INCISION PRIOR TO SKIN CLOSURE. THE REMAINDER OF THE DRAPE WAS REMOVED WITHOUT ISSUE. BACITRACIN OINTMENT WAS INITIALLY USED FOR TREATMENT. THE SKIN INJURY PROGRESSED TO AN ULCERATION AND THE PATIENT WAS REFERRED TO A PLASTIC SURGEON. THE NURSE PRACTITIONER REPORTED THE PATIENT WILL REQUIRE A WOUND VAC DRESSING AND POSSIBLE SKIN GRAFTING.

  Patient problems: Ulceration

  MAUDE report 7365784 ↗
• InjuryMar 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE PRACTITIONER REPORTED A PATIENT EXPERIENCED REDNESS, INFLAMMATION AND A BLISTER/ ULCER (APPROXIMATE SIZE 2" X 3") WHEN A 6640EZ 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE WAS REMOVED NEAR THE INCISION PRIOR TO SKIN CLOSURE FOLLOWING A THREE-HOUR SPINAL PROCEDURE. THE PATIENT WAS INITIALLY TREATED WITH BACITRACIN OINTMENT. THE SKIN INJURY PROGRESSED TO AN ULCERATION AND A PLASTIC SURGERY CONSULT WAS REQUIRED. THE PATIENT WAS REPORTEDLY IMPROVING UTILIZING A "WET TO DRY" DRESSING CHANGE MANAGEMENT.

  Patient problems: Ulceration

  MAUDE report 7365766 ↗
• InjuryMar 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE PRACTITIONER REPORTED A PATIENT EXPERIENCED A SKIN INJURY WHEN A 6640EZ 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE WAS REMOVED FOLLOWING A LEFT FRONTAL TEMPORAL CRANIOTOMY. THE PATIENT INITIALLY EXPERIENCED A DIME SIZED AREA OF SKIN REDNESS AND IRRITATION NEAR THE INCISION WHEN THE DRAPE WAS REMOVED PRIOR TO SKIN CLOSURE. BACITRACIN OINTMENT WAS INITIALLY USED FOR TREATMENT. THE PATIENT'S SKIN INJURY DID NOT IMPROVE, THE WOUND TEAM WAS CONSULTED AND WOUND DRESSINGS WERE USED FOR TREATMENT OF ULCERATION. A PLASTIC SURGERY CONSULT WAS LATER REQUIRED AND A SKIN GRAFT PROCEDURE WAS PERFORMED. THE INJURY WAS NOW REPORTEDLY HEALING.

  Patient problems: Ulceration

  MAUDE report 7363240 ↗