BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 3944587 · Received July 18, 2014

    Report

    Report Number
    2183959-2014-00311
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    June 25, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FAE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2014. EXPLANT DATE: (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS INDICATE BOTH CYLINDERS HAVE DAMAGE TO THE OUTER TUBE THAT WAS CAUSED BY A SHARP INSTRUMENT WHICH MAY HAVE OCCURRED DURING THE REMOVAL OF THE DEVICE. BOTH CYLINDERS FUNCTION AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIS SPECTRA DEVICE REMOVED 2 -3 WEEKS AFTER IMPLANT DATE DUE TO INFECTION. IT WAS NOTED THAT "THE PATIENT WAS QUITE FIBROTIC AND DIFFICULT TO DILATE". NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION WITH THIS EVENT. PATIENT OUTCOME INDICATED: "HE'S FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422493 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PROSTHESIS, PENILE FAE AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R