BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUR-STRIP STERILE SKIN CLOSURE

    MDR report key: 33214 · Received May 24, 1996

    Report

    Report Number
    MW4001314
    Event Type
    Malfunction
    Date Received
    May 24, 1996
    Report Date
    July 31, 1995
    Manufacturer
    INMAMEDI
    Product Code
    FPX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER SWITCHING TO THE NEW STRIP STERILE SKIN CLOSURES FROM THE MUCH PREFERRED, BETTER QUALITY STRIP SKIN CLOSURES, ALL RPTR HEARS FROM SURGEONS AND RESIDENTS ARE COMPLAINTS ABOUT THE PRODUCT. THE STRIP CLOSURES DO NOT WORK. THE STRIP CLOSURES DO NOT STICK AS WELL AS THE OTHER BRAND STRIPS. FREQUENT REPLACEMENT OF THE INEFFECTIVE STRIP SKIN CLOSURES INCREASE SURGICAL MORBIDITY OF THE WOUND. VERY BAD SCARS ARE LEFT. ANY GAIN IN COST DIFFERENTIAL IS DEFEATED BY USING THE LOW QUALITY STRIP CLOSURES DUE TO FREQUENT REPLACEMENT OF THESE INEFFECTIVE STRIPS. THE STRIP SKIN CLOSURES ARE UNSATISFACTORY AND RPTR STRONGLY RECOMMENDS THAT HOSP IMMEDIATELY SWITCH BACK TO THE GOOD STRIPS THAT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHUR-STRIP STERILE SKIN CLOSURE SKIN CLOSURE FPX INMAMEDI S-105 4259311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA