BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RXVTU-1

    MDR report key: 375723 · Received January 4, 2002

    Report

    Report Number
    MW4003188
    Event Type
    Malfunction
    Date Received
    January 4, 2002
    Report Date
    January 4, 2002
    Manufacturer
    ENCORE MEDICAL INC
    Product Code
    NHU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE DEVICE IS NOT SEALED IN A MANNER THAT PREVENTS IT FROM RANDOMLY BEING HANDLED. IT WAS JUST IN A BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RXVTU-1 VACUUM ERECTION SYSTEM NHU ENCORE MEDICAL INC NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO