BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTOUCH LATEX EXAMINATION GLOVES

    MDR report key: 17424 · Received November 4, 1994

    Report

    Report Number
    MW1003904
    Event Type
    Malfunction
    Date Received
    November 4, 1994
    Report Date
    November 2, 1994
    Manufacturer
    AMERICAN MEDICAL PRODUCTS, INC.
    Product Code
    LYY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    AFTER RECEIVING SAMPLES OF THE THE GLOVES, THE RPTR PLACED AN ORDER. HE STATED THAT THE GLOVES HE RECEIVED ARE DIFFERENT FROM THE SAMPLES; THEY ARE WEAK, POWDERY AND HAVE A HEAVY LATEX SMELL. THE RPTR IS QUESTIONING WHETHER OR NOT THE GLOVES ARE UP TO FDA STANDARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTOUCH LATEX EXAMINATION GLOVES GLOVES LYY AMERICAN MEDICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *