BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERI-STRIP WOUND CLOSURES (REINFORCED)

    MDR report key: 1612559 · Received February 15, 2010

    Report

    Report Number
    2110898-2010-00019
    Event Type
    Injury
    Date Received
    February 15, 2010
    Date of Event
    February 9, 2010
    Report Date
    February 10, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    FPX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    PATIENT (WHO IS A NURSE) REPORTED DEVELOPING 2 BIG BLISTERS AND MANY, RAISED, RED, SMALLER BLISTERS COVERING THE ENTIRE AREA UNDER THE STRIPS AND BEYOND, FOLLOWING WRIST SURGERY. COMPOUND BENZOIN TINCTURE WAS USED WITH THE STERI-STRIPS. PATIENT WAS TREATED WITH SILVADENE AND 2 DOSES OF LEVAQUIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-STRIP WOUND CLOSURES (REINFORCED) NA FPX 3M HEALTH CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention COMPOUND BENZOIN TINCTURE C1544 WAS USED UNDER THE| STERI-STRIP AS AN ADHESIVE ADJUNCT.