BEUDAMED
    FDA Adverse Event Other Summary report: N

    LATEX TOE SHIELD

    MDR report key: 72457 · Received March 3, 1997

    Report

    Report Number
    MW1010864
    Event Type
    Other
    Date Received
    March 3, 1997
    Report Date
    March 3, 1997
    Manufacturer
    LIQUID RUBBER APPLIANCE LABORATORIES, INC.
    Product Code
    MNE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PODIATRIST REPORTS THAT 3 OR 4 OF HIS PTS IN THE LAST 1 1/2 YRS HAVE HAD ALLERGIC REACTIONS INCLUDING LOCALIZED ITCHING, REDNESS, AND SWELLING AFTER USING LATEX TOE SHIELDS. DR'S CONCERN IS THAT THIS MAY SENSITIZE PTS TO LATEX AND LATER HEAD TO ANAPHYLACTIC REACTIONS UPON EXPOSURE TO OTHER LATEX PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LATEX TOE SHIELD LATEX TOE SHIELD MNE LIQUID RUBBER APPLIANCE LABORATORIES, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other