BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUR-STRIP SKIN CLOSURE

    MDR report key: 33213 · Received May 24, 1996

    Report

    Report Number
    MW4001312
    Event Type
    Malfunction
    Date Received
    May 24, 1996
    Report Date
    June 29, 1995
    Manufacturer
    INMAN MEDICAL CORP.
    Product Code
    FPX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CURRENT SKIN CLOSURE TAPES, STRIPS ARE MARKEDLY INFERIOR TO ANOTHER BRAND STRIPS. SURGEON IS EXPERIENCING COMPLICATIONS WITH SURGICAL WOUND CLOSURES IN INFANTS BECAUSE THE STRIPS ARE OVERLY STIFF AND HAVE POOR ADHESIVE PROPERTIES. SURGEON NEEDS THE OTHER BRAND STRIPS FOR USE IN PEDIATRIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHUR-STRIP SKIN CLOSURE SKIN CLOSURE FPX INMAN MEDICAL CORP. S-101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA