BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATE/DEFLATE PUMP

    MDR report key: 93814 · Received July 26, 1994

    Report

    Report Number
    93814
    Event Type
    Injury
    Date Received
    July 26, 1994
    Date of Event
    May 31, 1994
    Report Date
    July 25, 1994
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THIS NOW 66 YEAR OLD MALE PT UNDERWENT INSERTION OF A PENILE PROSTHESIS IN FEBRUARY 1992. THE FOLLOWING IMPLANTS WERE PLACED AT THAT TIME: ULTREX RESERVOIR, 100 ML, P/N 7241130, CYLINDERS, 21 CM X 12.0 MM, P/N 72401127, P/N 72400270, AND INFLATE/DEFLATE PUMP, P/N 72400151, AT SOME UNK DATE, THE PT AND PHYSICIAN HAD BEEN NOTIFIED BY CO THAT HIS PUMP NUMBER WAS AMONG A BATCH OF POSSIBLE DEFECTIVE PUMPS. IN APRIL 1994, THE PT PRESENTED TO THE PHYSICIAN WITH A NON-FUNCTIONING PROSTHESIS. ON 5/31/94, THE PT UNDERWENT REMOVAL OF THE PENILE PROSTHESIS AND INSERTION OF A NEW 1 CM CYLINDER PROSTHESIS, CORPOROTOMY, PENILE STRAIGHTENING, AND HYDROSTATIC DILITATION OF THE RESERVOIR CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS INFLATE/DEFLATE PUMP Implant UNK FHW AMERICAN MEDICAL SYSTEMS 72400151 2039P 003

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR