BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 2885028 · Received December 18, 2012

    Report

    Report Number
    2183959-2012-03377
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 11, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTIFICIAL URINARY SPHINCTER REVISION SURGERY WILL BE REPORTED ON Q4 ASR FOR 2012. SHOULD ADDITIONAL 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

    IT WAS REPORTED THAT THE PT HAD HIS DEVICE REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS BECAUSE OF PT DISSATISFACTION. APPARENTLY, THE DISSATISFACTION WAS DUE TO AN "IMPLANT THAT HAD MIGRATED A BIT AND WAS NOT WORKING AS INTENDED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA CONCEALABLE PENILE PROSTHESIS PENILE PROSTHESIS FAE AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R EXPLANTED:| IMPLANTED:| ARTIFICIAL URINARY SPHINCTER