BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERI-STRIP WOUND CLOSURES (REINFORCED)

    MDR report key: 1780852 · Received July 26, 2010

    Report

    Report Number
    2110898-2010-00090
    Event Type
    Other
    Date Received
    July 26, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 22, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    FPX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE WAS NOT RETURNED TO 3M FOR EVALUATION, THEREFORE, NO EVALUATION OR CONCLUSION CAN BE DRAWN. PRODUCT LABELING STATES THE EXPECTED AES WITH PRODUCT USE IN THE WARNING SECTION, SHOWN BELOW: WARNINGS. THE DEVELOPMENT OF POSTOPERATIVE EDEMA MAY CAUSE SKIN SHEARING, SKIN BLISTERING, OR LOSS OF TAPE ADHESION TO OCCUR AT EITHER END OF THE STRIP. APPLICATION OF ANY SURGICAL TAPE OR ADHESIVE SKIN CLOSURE MAY RESULT IN SKIN STRIPPING UPON REMOVAL. AS WITH ALL ADHESIVE PRODUCTS APPLIED TO THE SKIN, A SMALL PERCENTAGE OF INDIVIDUALS MAY EXPERIENCE HYPOPIGMENTATION OR HYPERPIGMENTATION FOLLOWING REMOVAL. OCCASIONAL CASES OF MILD ACNE AND FOLLICULITIS HAVE BEEN OBSERVED IN TESTING ON HEALTHY VOLUNTEERS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SHE HAD A HYSTERECTOMY ON (B)(6) 2009, WITH STERI-STRIPS ON THE INCISION COVERED BY A BULKY DRESSING FRAMED WITH DURAPORE TAPE. SHE SAID THAT SHE HAD DIME SIZE BLISTERS ON BOTH ENDS OF THE STRIP ON THE RIGHT END OF THE INCISION. WHEN THE DOCTOR TRIED TO REMOVE IT, HER SKIN CAME OFF WITH THE TAPE. SHE SAID IT WAS WORSE ON THE UPPER EDGE ON THE LEFT SIDE. SHE SAID SHE HAS BLACK SKIN, AND SINCE SEPTEMBER HAS USED KELOCOTE, COCOA BUTTER, ETC., BUT STILL HAS DARK SPOTS. SHE SAID SHE TRIED AMBI, AN OTC BLEACHING CREAM FOR BLACK SKIN AND IT WORKED A LITTLE BUT ONLY IN THE CENTER. SHE MENTIONED WHEN SHE WAS (B)(6) SHE GOT BURNED ON A POT, BLISTERED, AND NOW (B)(6) STILL HAS A DARK SPOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-STRIP WOUND CLOSURES (REINFORCED) NONE FPX 3M HEALTH CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other