BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXCARE COMFORT BANDAGES 1"

    MDR report key: 411887 · Received June 11, 2002

    Report

    Report Number
    MW4003330
    Event Type
    Malfunction
    Date Received
    June 11, 2002
    Date of Event
    June 8, 2002
    Report Date
    June 11, 2002
    Manufacturer
    3M HEALTH CARE, LTD
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR PURCHASED ONE BOX OF NEXCARE CONFORT BANDAGES 1" STRIPS (NON-ANTIBIOTICS) FOR USE IN THEIR HOME AND AT THEIR WORK PLACE. THEY OPENED THE BOX AND REMOVED SOME OF THE BANDAGES TO TAKE TO WORK. AS THEY SEPARATED THE BANDAGES, THEY NOTED APPROX THREE OF THE 30 INDIVIDUAL BANDAGE PACKAGES WERE SATURATED WITH WHAT APPEARED TO BE SOME KIND OF LIQUID/OINTMENT. THE FOREIGN MATERIAL APPEARED TO BE COMING FROM INSIDE THE PACKAGING RATHER THAN FROM THE OUTSIDE IN. THE LABELING OF SOME OF THE INDIVIDUAL BANDAGE PACKAGES ADJACENT TO THE SATURATED PACKAGES WAS SMUDGED APPARENTLY FROM THE MOISTURE SPREAD BY THE THREE SATURATED PACKAGES. USER WAS CONCERNED THE STERILITY OF THE PRODUCT MIGHT BE COMPROMISED OR THAT THE PRODUCT MAY HAVE BEEN TAMPERED WITH. THEY DID NOT USE THE PRODUCT. NO ILLNESS WAS REPORTED. USER REPORTED THEIR COMPLAINT TO THE MFG CO WHO REQUESTED THEY RETURN THE PRODUCT TO THEM FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXCARE COMFORT BANDAGES 1" BANDAGE KGX 3M HEALTH CARE, LTD NA 2046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA