BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSAT-T-VAC PUMP

    MDR report key: 7600499 · Received June 13, 2018

    Report

    Report Number
    MW5077827
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    December 8, 2017
    Report Date
    June 13, 2018
    Manufacturer
    POS-T-VAC INC.
    Product Code
    LKY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT STATED THE USE OF THE VACUUM PUMP CAUSED HIM DAMAGE. HIS ERECTION DID NOT FEEL NATURAL. PATIENT HAD SCAR TISSUE AND HIS PENIS NO LONGER STANDS UP ALL CAUSED BY THE USE OF THE VACUUM PUMP. PATIENT HAS STOPPED USING THE VACUUM PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439758 POSAT-T-VAC PUMP DEVICE, EXTERNAL PENILE RIGIDITY LKY POS-T-VAC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR