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Ioban™ 2 6651EZRecalls & reported problems

3m Company · 3M™ Ioban™ 2 Antimicrobial Incise Drape 6651EZ · Class 2

All models of Ioban 2 (8)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30707387507382), received between Jun 7, 2022 and Jun 7, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Skin Tears1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    MEDWATCH 0500770000-2022-8017 WAS RECEIVED FROM THE FDA: AN ELDERLY PATIENT WITH LARGE SKIN TEAR ON LOWER EXTREMITY. IOBAN 2 WOUND DRESSING WAS BEING REMOVED AFTER CARDIAC SURGICAL PROCEDURE. IT WAS NOTED WHEN THE DRAPE WAS BEING REMOVED FROM THE LOWER EXTREMITY, THE PATIENT'S SKIN WAS ADHERED TO THE DRAPE. THE STAFF MADE ATTEMPTS TO CAREFULLY REMOVE THE REMAINING DRAPE. IT WAS DIFFICULT TO SEE THAT ADDITIONAL SKIN WAS ADHERED AND WHEN THE DRAPE WAS COMPLETELY REMOVED, THE SKIN TEAR WAS NOTED. THE PATIENT WILL FOLLOW UP FOR WOUND CARE. ADDITIONAL INFORMATION RECEIVED UPON FOLLOW-UP WITH THE REPORTER: WHEN THE SURGICAL PROCEDURE WAS COMPLETED, THE 3M IOBAN 2 ANTIMICROBIAL INCISE DRAPE WAS REMOVED SLOWLY BY THE OPERATING ROOM STAFF, FROM THE CHEST DOWN TOWARDS THE RIGHT LOWER EXTREMITY, AND IT WAS NOTED THAT SOME OF THE PAPER-THIN SKIN WAS ADHERED TO THE DRAPE. THE REMAINING PARTS OF THE DRESSINGS WERE REMOVED AND AFTER THE DRAPE WAS COMPLETELY REMOVED, IT WAS IDENTIFIED THAT A LARGE PORTION OF THE SKIN WAS SHEARED ON THE LOWER RIGHT EXTREMITY. IT WAS DIFFICULT TO CONFIRM THE SKIN WAS ADHERED TO THE REMAINING PART OF THE DRAPE DUE TO HIS PAPER-THIN SKIN BLENDING INTO THE DRAPE. A XER

    Patient problems: Skin Tears

    MAUDE report 14627265 ↗

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Sources and updates

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