BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERI-STRIP WOUND CLOSURE SYSTEM

    MDR report key: 2704546 · Received November 10, 2009

    Report

    Report Number
    2110898-2009-00038
    Event Type
    Injury
    Date Received
    November 10, 2009
    Date of Event
    June 17, 2009
    Report Date
    November 10, 2009
    Manufacturer
    3M HEALTH CARE
    Product Code
    FPX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT LABELING CLEARLY STATE 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 OF HYPERPIGMENTATION FOLLOWING REMOVAL. OCCASIONAL CASES OF MILD ACNE AND FOLLICULITIS HAVE BEEN OBSERVED IN TESTING ON HEALTHY VOLUNTEERS.

    Description of Event or Problem · 1

    ON (B)(6) 2009, IT WAS REPORTED THAT A PT HAD A BREAST BIOPSY AND INCISION WAS CLOSED WITH STERI-STRIPS AND TEGADERM PROVIDED IN THE STERI-STRIP WOUND CLOSURE SYSTEM. BLISTERS DEVELOPED AND THEN CELLULITIS. PT CONSULTED PLASTIC SURGEON ON (B)(6) 2009 AND WAS TREATED WITH SILVADENE AND BACTRIM. PT DEVELOPED HYPERPIGMENTATION AND IS BEING WATCHED BY PLASTIC SURGEON FOR 6 MONTHS TO BE FOLLOWED BY TREATMENT WITH LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-STRIP WOUND CLOSURE SYSTEM NONE FPX 3M HEALTH CARE W8512 2014-03AL

    Patients

    Seq Age Sex Outcome Treatment
    1