BEUDAMED
    FDA Adverse Event Other Summary report: N

    NU GAUZE PACKING STRIP/IODOFORM

    MDR report key: 341090 · Received July 9, 2001

    Report

    Report Number
    1618732-2001-00057
    Event Type
    Other
    Date Received
    July 9, 2001
    Date of Event
    June 7, 2001
    Report Date
    July 6, 2001
    Manufacturer
    JOHNSON & JOHNSON MEDICAL, INC.
    Product Code
    GEL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THEIR DR HAD PRESCRIBED A DRESSING FOR THEIR CUT/WOUND LOCATED ON THEIR LEG. THE PRESCRIBED DRESSING WAS UNAVAILABLE AND THE PHARMACIST HAD RECOMMENDED THE PACKING STRIPS. THE CONSUMER REPORTED EXPERIENCING EXTREME BURNING AFTER APPLYING THE PACKING STRIP. THEY CONTINUED USE OF THE PRODUCT AND DEVELOPED BLISTERS. THE CONSUMER DENIED ANY KNOWN SENSITIVITIES. THE CONSUMER REPORTS THEY MUST HAVE A "SKIN GRAPH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30881 NU GAUZE PACKING STRIP/IODOFORM GAUZE, SPONGE, MEDICATED GEL JOHNSON & JOHNSON MEDICAL, INC. NA 2659Y2; 665-56

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other