BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODI-GARD GLOVE

    MDR report key: 18995 · Received January 17, 1995

    Report

    Report Number
    MW1004772
    Event Type
    Malfunction
    Date Received
    January 17, 1995
    Report Date
    January 12, 1995
    Manufacturer
    HOSPITAL THERAPY PRODUCTS, INC.
    Product Code
    LYY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ASSISTING PT IN WHIRLPOOL. GLOVES LEAKED, PERMITTING EMPLOYEE EXPOSURE. EVENT DATES INDICATED AS 1/10 AND 11/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BODI-GARD GLOVE AXILLARY LENGTH GLOVES LYY HOSPITAL THERAPY PRODUCTS, INC. 3041K

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other