BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERI-STRIP WOUND CLOSURES

    MDR report key: 1668098 · Received April 19, 2010

    Report

    Report Number
    2110898-2010-00040
    Event Type
    Injury
    Date Received
    April 19, 2010
    Date of Event
    February 21, 2010
    Report Date
    March 1, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    FPX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    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 REPORTED ON 03/01/2010 THAT AFTER LEFT WRIST REPLACEMENT SURGERY CONDUCTED ON (B) (6) 2010, STERI-STRIPS WERE USED AND THE SKIN CAME OFF WITH THE STRIPS. THE INJURY WAS TREATED WITH A CREAM THAT WAS MASSAGED WITH A MACHINE AT THERAPY. PATIENT REPORTED ON (B) (6) 2010 THAT HER SKIN HAD NOT GROWN BACK AND THERE IS SCARRING.

    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 52 YR Disability