Steri-Drape™ Ioban™ 2 6619Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 50707387444353), received between Mar 14, 2018 and Jul 11, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Human-Device Interface Problem” (7 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A NURSE REPORTED A WHITE 63-YEAR-OLD FEMALE WEIGHING 66.7 KG ALLEGEDLY EXPERIENCED A 2ND DEGREE SKIN AVULSION LOCALIZED TO THE INCISIONAL EDGES WITH SURROUNDING AREA ERYTHEMA, SWELLING, BLISTERS, SKIN STRIPPING/SKIN TEAR, BURNING SENSATION AND PAIN POSTOPERATIVE REMOVAL OF THE 3M¿ STERI-DRAPE¿ LARGE ISOLATION DRAPE WITH IOBAN¿ 2 INCISE FILM AND POUCH, 6619. NO MEDICAL TREATMENT WAS REQUIRED TO PREVENT DEATH OR SERIOUS INJURY, AND IT WAS NOTED THERE WAS AN OVERALL DELAY IN WOUND HEALING, REQUIRED PAIN MANAGEMENT AND WOUND CARE TREATMENT, DESCRIBED AS VARIOUS WOUND THERAPY BASED ON REFERRAL TO OCCUPATIONAL THERAPY AND PHYSICAL THERAPY FOR WOUND MONITORING. THE PATIENT HEALED WITHIN 90 DAYS WITH NO PERMANENT LOSS, WITH NO KNOWN RISK FOR PERMANENT OR FUNCTIONAL IMPAIRMENT, NO LIFE-THREATENING CONDITIONS AND DID NOT REQUIRED HOSPITALIZATION. IT WAS CONFIRMED THERE WAS NO DIFFICULTY REMOVING THE 3M¿ STERI-DRAPE¿ LARGE ISOLATION DRAPE WITH IOBAN¿ 2 INCISE FILM AND POUCH, 6619, AND NO OTHER PRODUCTS WERE USED TO AID WITH REMOVAL OF THE 3M PRODUCT.

  Patient problems: Burning Sensation; Erythema; Pain; Skin Tears; Swelling/ Edema

  MAUDE report 17302372 ↗
• InjuryJul 11, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A NURSE REPORTED A WHITE 28-YEAR-OLD MALE WEIGHING 109.9 KG ALLEGEDLY EXPERIENCED A 2ND DEGREE SKIN AVULSION LOCALIZED TO THE INCISIONAL EDGES WITH SURROUNDING AREA ERYTHEMA, SWELLING, BLISTERS, SKIN STRIPPING/SKIN TEAR, BURNING SENSATION AND PAIN POSTOPERATIVE REMOVAL OF THE 3M¿ STERI-DRAPE¿ LARGE ISOLATION DRAPE WITH IOBAN¿ 2 INCISE FILM AND POUCH, 6619. NO MEDICAL TREATMENT WAS REQUIRED TO PREVENT DEATH OR SERIOUS INJURY, AND IT WAS NOTED THERE WAS AN OVERALL DELAY IN WOUND HEALING, REQUIRED PAIN MANAGEMENT AND WOUND CARE TREATMENT, DESCRIBED AS VARIOUS WOUND THERAPY BASED ON REFERRAL TO OCCUPATIONAL THERAPY AND PHYSICAL THERAPY FOR WOUND MONITORING. THE PATIENT HEALED WITHIN 90 DAYS WITH NO PERMANENT LOSS, WITH NO KNOWN RISK FOR PERMANENT OR FUNCTIONAL IMPAIRMENT, NO LIFE-THREATENING CONDITIONS AND DID NOT REQUIRED HOSPITALIZATION. IT WAS CONFIRMED THERE WAS NO DIFFICULTY REMOVING THE 3M¿ STERI-DRAPE¿ LARGE ISOLATION DRAPE WITH IOBAN¿ 2 INCISE FILM AND POUCH, 6619, AND NO OTHER PRODUCTS WERE USED TO AID WITH REMOVAL OF THE 3M PRODUCT.

  Patient problems: Burning Sensation; Erythema; Pain; Skin Tears; Swelling/ Edema

  MAUDE report 17302359 ↗
• InjuryJul 11, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A NURSE REPORTED A WHITE 58-YEAR-OLD FEMALE WEIGHING 70.3KG ALLEGEDLY EXPERIENCED A 2ND DEGREE SKIN AVULSION LOCALIZED TO THE INCISIONAL EDGES WITH SURROUNDING AREA ERYTHEMA, SWELLING, BLISTERS, SKIN STRIPPING/SKIN TEAR, BURNING SENSATION AND PAIN POSTOPERATIVE REMOVAL OF THE 3M¿ STERI-DRAPE¿ LARGE ISOLATION DRAPE WITH IOBAN¿ 2 INCISE FILM AND POUCH, 6619. NO MEDICAL TREATMENT WAS REQUIRED TO PREVENT DEATH OR SERIOUS INJURY, AND IT WAS NOTED THERE WAS AN OVERALL DELAY IN WOUND HEALING, REQUIRED PAIN MANAGEMENT AND WOUND CARE TREATMENT, DESCRIBED AS VARIOUS WOUND THERAPY BASED ON REFERRAL TO OCCUPATIONAL THERAPY AND PHYSICAL THERAPY FOR WOUND MONITORING. THE PATIENT HEALED WITHIN 90 DAYS WITH NO PERMANENT LOSS, WITH NO KNOWN RISK FOR PERMANENT OR FUNCTIONAL IMPAIRMENT, NO LIFE-THREATENING CONDITIONS AND DID NOT REQUIRED HOSPITALIZATION. IT WAS CONFIRMED THERE WAS NO DIFFICULTY REMOVING THE 3M¿ STERI-DRAPE¿ LARGE ISOLATION DRAPE WITH IOBAN¿ 2 INCISE FILM AND POUCH, 6619, AND NO OTHER PRODUCTS WERE USED TO AID WITH REMOVAL OF THE 3M PRODUCT.

  Patient problems: Burning Sensation; Erythema; Pain; Skin Tears; Swelling/ Edema

  MAUDE report 17302356 ↗
• InjuryJul 11, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A NURSE REPORTED A PATIENT ALLEGEDLY EXPERIENCED A 2ND DEGREE SKIN AVULSION LOCALIZED TO THE INCISIONAL EDGES WITH SURROUNDING AREA ERYTHEMA, SWELLING, BLISTERS, SKIN STRIPPING/SKIN TEAR, BURNING SENSATION AND PAIN POSTOPERATIVE REMOVAL OF THE 3M¿ STERI-DRAPE¿ LARGE ISOLATION DRAPE WITH IOBAN¿ 2 INCISE FILM AND POUCH, 6619. NO MEDICAL TREATMENT WAS REQUIRED TO PREVENT DEATH OR SERIOUS INJURY, AND IT WAS NOTED THERE WAS AN OVERALL DELAY IN WOUND HEALING, REQUIRED PAIN MANAGEMENT AND WOUND CARE TREATMENT, DESCRIBED AS VARIOUS WOUND THERAPY BASED ON REFERRAL TO OCCUPATIONAL THERAPY AND PHYSICAL THERAPY FOR WOUND MONITORING. THE PATIENT HEALED WITHIN 90 DAYS WITH NO PERMANENT LOSS, WITH NO KNOWN RISK FOR PERMANENT OR FUNCTIONAL IMPAIRMENT, NO LIFE-THREATENING CONDITIONS AND DID NOT REQUIRED HOSPITALIZATION. IT WAS CONFIRMED THERE WAS NO DIFFICULTY REMOVING THE 3M¿ STERI-DRAPE¿ LARGE ISOLATION DRAPE WITH IOBAN¿ 2 INCISE FILM AND POUCH, 6619, AND NO OTHER PRODUCTS WERE USED TO AID WITH REMOVAL OF THE 3M PRODUCT.

  Patient problems: Burning Sensation; Erythema; Pain; Skin Tears; Swelling/ Edema

  MAUDE report 17299448 ↗
• InjuryJul 11, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A NURSE REPORTED A WHITE 43-YEAR-OLD FEMALE WEIGHING 78.9 KG ALLEGEDLY EXPERIENCED A 2ND DEGREE SKIN AVULSION LOCALIZED TO THE INCISIONAL EDGES WITH SURROUNDING AREA ERYTHEMA, SWELLING, BLISTERS, SKIN STRIPPING/SKIN TEAR, BURNING SENSATION AND PAIN POSTOPERATIVE REMOVAL OF THE 3M¿ STERI-DRAPE¿ LARGE ISOLATION DRAPE WITH IOBAN¿ 2 INCISE FILM AND POUCH, 6619. NO MEDICAL TREATMENT WAS REQUIRED TO PREVENT DEATH OR SERIOUS INJURY, AND IT WAS NOTED THERE WAS AN OVERALL DELAY IN WOUND HEALING, REQUIRED PAIN MANAGEMENT AND WOUND CARE TREATMENT, DESCRIBED AS VARIOUS WOUND THERAPY BASED ON REFERRAL TO OCCUPATIONAL THERAPY AND PHYSICAL THERAPY FOR WOUND MONITORING. THE PATIENT HEALED WITHIN 90 DAYS WITH NO PERMANENT LOSS, WITH NO KNOWN RISK FOR PERMANENT OR FUNCTIONAL IMPAIRMENT, NO LIFE-THREATENING CONDITIONS AND DID NOT REQUIRED HOSPITALIZATION. IT WAS CONFIRMED THERE WAS NO DIFFICULTY REMOVING THE 3M¿ STERI-DRAPE¿ LARGE ISOLATION DRAPE WITH IOBAN¿ 2 INCISE FILM AND POUCH, 6619, AND NO OTHER PRODUCTS WERE USED TO AID WITH REMOVAL OF THE 3M PRODUCT.

  Patient problems: Burning Sensation; Erythema; Pain; Skin Tears; Swelling/ Edema

  MAUDE report 17298585 ↗
• InjuryJul 11, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A NURSE REPORTED A WHITE 59-YEAR-OLD MALE WEIGHING 90.7 KG ALLEGEDLY EXPERIENCED A 2ND DEGREE SKIN AVULSION LOCALIZED TO THE INCISIONAL EDGES WITH SURROUNDING AREA ERYTHEMA, SWELLING, BLISTERS, SKIN STRIPPING/SKIN TEAR, BURNING SENSATION AND PAIN POSTOPERATIVE REMOVAL OF THE 3M¿ STERI-DRAPE¿ LARGE ISOLATION DRAPE WITH IOBAN¿ 2 INCISE FILM AND POUCH, 6619. NO MEDICAL TREATMENT WAS REQUIRED TO PREVENT DEATH OR SERIOUS INJURY, AND IT WAS NOTED THERE WAS AN OVERALL DELAY IN WOUND HEALING, REQUIRED PAIN MANAGEMENT AND WOUND CARE TREATMENT, DESCRIBED AS VARIOUS WOUND THERAPY BASED ON REFERRAL TO OCCUPATIONAL THERAPY AND PHYSICAL THERAPY FOR WOUND MONITORING. THE PATIENT HEALED WITHIN 90 DAYS WITH NO PERMANENT LOSS, WITH NO KNOWN RISK FOR PERMANENT OR FUNCTIONAL IMPAIRMENT, NO LIFE-THREATENING CONDITIONS AND DID NOT REQUIRED HOSPITALIZATION. IT WAS CONFIRMED THERE WAS NO DIFFICULTY REMOVING THE 3M¿ STERI-DRAPE¿ LARGE ISOLATION DRAPE WITH IOBAN¿ 2 INCISE FILM AND POUCH, 6619, AND NO OTHER PRODUCTS WERE USED TO AID WITH REMOVAL OF THE 3M PRODUCT.

  Patient problems: Burning Sensation; Erythema; Pain; Skin Tears; Swelling/ Edema

  MAUDE report 17297896 ↗
• InjuryJul 10, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A NURSE REPORTED A 43-YEAR-OLD FEMALE ALLEGEDLY EXPERIENCED A 2ND DEGREE SKIN AVULSION LOCALIZED TO THE INCISIONAL EDGES WITH SURROUNDING AREA ERYTHEMA, SWELLING, BLISTERS, SKIN STRIPPING/SKIN TEAR, BURNING SENSATION AND PAIN POSTOPERATIVE REMOVAL OF THE 3M¿ STERI-DRAPE¿ LARGE ISOLATION DRAPE WITH IOBAN¿ 2 INCISE FILM AND POUCH, 6619. IT WAS NOTED THERE WAS AN OVERALL DELAY IN WOUND HEALING, REQUIRED PAIN MANAGEMENT AND WOUND CARE TREATMENT, DESCRIBED AS VARIOUS WOUND THERAPY BASED ON REFERRAL TO OCCUPATIONAL THERAPY AND PHYSICAL THERAPY FOR WOUND MONITORING. NO MEDICAL TREATMENT WAS REQUIRED TO PREVENT DEATH OR SERIOUS INJURY. THE PATIENT HEALED WITHIN 90 DAYS WITH NO PERMANENT LOSS, AND NO KNOWN RISK FOR PERMANENT OR FUNCTIONAL IMPAIRMENT, NO LIFE-THREATENING CONDITIONS AND DID NOT REQUIRE HOSPITALIZATION. IT WAS CONFIRMED THERE WAS NO DIFFICULTY REMOVING THE 3M¿ STERI-DRAPE¿ LARGE ISOLATION DRAPE WITH IOBAN¿ 2 INCISE FILM AND POUCH, 6619, AND NO OTHER PRODUCTS WERE USED TO AID WITH REMOVAL OF THE 3M PRODUCT.

  Patient problems: Burning Sensation; Erythema; Pain; Skin Tears; Swelling/ Edema

  MAUDE report 17288279 ↗
• MalfunctionMar 14, 2018Hole In Material

  THE PATIENT HAD A TOTAL HIP AND WE HAD STERI DRAPES (IOBAN) OF REFERENCE #6619. THE SCRUB TECHNICIAN HAS FOUND HOLES IN THESE BEFORE. THE OUTER PACKAGING WAS CHECKED CAREFULLY, WHICH WAS FINE, BUT THE INSIDE PACKAGING HAD A HOLE. THE SAME THING OCCURRED WITH THE SECOND ONE. WE HAD TO OPEN THREE DRAPES TO GET ONE THAT WAS WITHOUT BLEMISH. YESTERDAY, THERE WAS ALSO A PROBLEM WITH TWO DRAPES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7337577 ↗