BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS 700 LGX MS PUMP 12

    MDR report key: 1941599 · Received December 16, 2010

    Report

    Report Number
    1941599
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AMS
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US

    Narratives

    Description of Event or Problem · 1

    THE PENILE PUMP WAS REMOVED AND REPLACED WITH A NEW PENILE PUMP. THERE WAS A DIAGNOSIS OF PENILE PAIN FOLLOWING THE PENILE PROSTHESIS IMPLANT. THE PUMP WAS FUNCTIONING PROPERLY ACCORDING TO THE MD AND THE SALES REPRESENTATIVE. THE SALES REP SENT THE EXPLANT BACK TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS 700 LGX MS PUMP 12 PENILE PUMP FHW AMS 72404252 609718004

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR