BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 6134374 · Received November 30, 2016

    Report

    Report Number
    2183959-2016-00190
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 24, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FAE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REPORTED IN MODEL #/LOT #, IMPLANT DATE, AND DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS: THE TWO SPECTRA CYLINDERS WERE VISUALLY INSPECTED AND FUNCTIONALLY TESTED. ONE PERFORMED WITHIN SPECIFICATIONS. ONE CYLINDER HAD HOLES IN THE OUTER LAYER THAT WERE THE RESULT OF A SHARP INSTRUMENT THAT EXPOSED INNER SEGMENTS. THESE PROBABLY OCCURRED DURING REMOVAL. THIS CYLINDER FUNCTIONS AS INTENDED. ADDITIONAL INFORMATION REPORTED IN AGE/DATE OF BIRTH, DESCRIBE EVENT OR PROBLEM, DEVICE AVAILABLE FOR EVALUATION?, EVENT PROBLEM CODES, DEVICE EVALUATED BY MFR?, EVALUATION CODES, AND ADDITIONAL MFR NARRATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SPECTRA PENILE PROSTHESIS WAS REMOVED FOR UNKNOWN REASONS. NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED REVEALED THAT THE DEVICE WAS REMOVED DUE TO THE DEVICE REMAINING FLACCID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785696 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PROSTHESIS, PENILE FAE AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R