BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-COVER

    MDR report key: 16233 · Received September 19, 1994

    Report

    Report Number
    MW1003422
    Event Type
    Malfunction
    Date Received
    September 19, 1994
    Report Date
    September 15, 1994
    Manufacturer
    PARKER LABORATORIES, INC.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE LATEX THAT THE PROBES ARE MADE OF IS NOT HOMOGENEOUS AND IS FULL OF HOLES. THE RPTR IS CONCERNED THAT BODY FLUIDS CAN BE TRANSFERRED FROM ONE PT TO ANOTHER. THE HOSP HAS RECENTLY STARTED USING THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-COVER LATEX COVER FOR ULTRASOUND PROBE ITX PARKER LABORATORIES, INC. 4793

    Patients

    Seq Age Sex Outcome Treatment
    1 *