BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BATHMATE

    MDR report key: 3249256 · Received July 22, 2013

    Report

    Report Number
    MW5031063
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    July 20, 2013
    Report Date
    July 22, 2013
    Manufacturer
    DX PRODUCT LTD
    Product Code
    LKY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT COMPLAINED OF PAIN IN HIS PENIS AND ADVERSE SWELLING. PT SUFFERS FROM PEYRONIE'S DISEASE AND BOUGHT A PRODUCT CALLED BATHMATE THAT CLAIMED TO CURE SAID DISEASE. THE PRODUCT IS ALSO SOLD UNDER THE NAME OF HYDROMAX IN THE VARIATIONS OF HYDROMAX X40, HYDROMAX X30 AND BATHMATE GOLIATH. FOUR WEEKS OF THE BATHMATE X30 MODEL. PT ALSO OWN THE HYDROMAX X40 AND BATHMATE GOLIATH. DOSE OR AMOUNT: 20 MIN, FREQUENCY: DAY, ROUTE: INTRA. EVENT ABATED AFTER USE STOPPED DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340254 BATHMATE NONE LKY DX PRODUCT LTD X30 UNK
    340255 HYDROMAX NONE LKY DX PRODUCTS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention