BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 3010314 · Received March 12, 2013

    Report

    Report Number
    2183959-2013-00743
    Event Type
    Injury
    Date Received
    March 12, 2013
    Report Date
    February 22, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR WHETHER THE EVENTS REPORTED WERE ASSOCIATED WITH AMS OR NON-AMS DEVICES. SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT #2183959-2013-00742. IT WAS REPORTED IN THE JOURNAL OF SEXUAL MEDICINE THAT A RETROSPECTIVE REVIEW OF PTS WAS PERFORMED FOR PTS WHO HAD AN IPP PLACEMENT BETWEEN (B)(6) 2011 AND (B)(6) 2012. SIXTY ONE PTS WERE IMPLANTED WITH EITHER THE AMS 700CX/LGX DEVICE WITH A CONCEAL RESERVOIR OR ANOTHER MFR'S DEVICE. THIS STUDY REVIEWED RECORDS FOR PTS WHO HAD THEIR IPP RESERVOIRS PLACED "HIGH BENEATH THE RECTUS ABDOMINUS MUSCLE". EARLY POSTOPERATIVE COMPLICATIONS INCLUDED ONE SCROTAL HEMATOMA MANAGED EXPECTANTLY AND ONE CASE OF URINARY RETENTION THAT RESOLVED AFTER 4 DAYS OF CATHETERIZATION DECOMPRESSION. IT WAS ALSO NOTED THAT TWO PTS PRESENTED WITH PALPABLE UPBR (UROLOGIC PROSTHETIC BALLOONS AND RESERVOIRS) AT 8 AND 24 WEEKS FOLLOWING SURGERY: ONE HAD RESERVOIR HERNIATION DUE TO INADEQUATE CEPHALAD LOCATION OF HIS SUBMUSCULAR SPACE AND ONE HAD RESERVOIR THAT WAS PLACED INTO A SUBCUTANEOUS LOCATION. BOTH RESERVOIRS WERE SUCCESSFULLY REPLACED INTO A HIGH IPSILATERAL SUBMUSCULAR LOCATION WITH NO ADD'L COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104451 AMS INFLATABLE PENILE PROSTHESIS PENILE PROSTHESIS FAE AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R