BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERI-STRIP WOUND CLOSURES

    MDR report key: 1693090 · Received May 12, 2010

    Report

    Report Number
    2110898-2010-00045
    Event Type
    Injury
    Date Received
    May 12, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 23, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    FPX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER DID NOT HAVE A LOT CODE FOR THE PRODUCT. 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

    A PT HAS BREAST AUGMENTATION AND ABDOMINOPLASTY AFTER WHICH IT WAS REPORTED THAT REDNESS, ITCHING AND SLIGHT BUMPINESS DEVELOPED ALONG THE INCISION LINE EVERYWHERE UNDER THE STRIPS BUT NOT BEYOND THE STRIPS. STERI-STRIPS WERE USED WITH MASTISOL WHICH WAS REPORTED TO POSSIBLY BE INVOLVED IN THE REACTION. PT WAS TREATED WITH A MEDROL DOSE PACK AND TEMOVATE WHICH WAS REPORTED TO NOT BE OF HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-STRIP WOUND CLOSURES TAPE, SKIN CLOSURE FPX 3M HEALTH CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MASTISOL