BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 3010301 · Received March 12, 2013

    Report

    Report Number
    2183959-2013-00746
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    July 18, 2012
    Report Date
    February 15, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. THE RIGHT CYLINDER PERFORMED WITHIN SPECIFICATIONS. THE LEFT CYLINDER HAD HOLES IN THE OUTER TUBE THAT APPEARED TO BE CAUSED A SHARP INSTRUMENT. THE LEFT CYLINDER FUNCTIONS AS INTENDED. UNABLE TO DETERMINE IF THERE IS A RELATIONSHIP TO THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REMOVED DUE TO "CYLINDER RUPTURE", AND "DISLOCATION". THE PATIENT WAS RE-IMPLANTED WITH AN AMS AMBICOR PENILE PROSTHESIS ON THE SAME DAY AS THE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104554 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PENILE PROSTHESIS FAE AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R