BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M STERI-STRIP WOUND CLOSURES

    MDR report key: 2969627 · Received February 7, 2013

    Report

    Report Number
    2110898-2013-00003
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    October 7, 2012
    Report Date
    January 18, 2013
    Manufacturer
    3M HEALTH CARE
    Product Code
    FPX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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'S INCISIONAL SITE WAS TREATED WITH MASTISOL ADHESIVE AND STERI-STRIP. RED, RAISED RASH AND OOZING BLISTERS OCCURRED 3-DAY POST-USE. PATIENT TREATED WITH STEROID DOSE PACK AND ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52564 3M STERI-STRIP WOUND CLOSURES WOUND CLOSURES FPX 3M HEALTH CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention MASTISOL ADHESIVE