BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    MDR report key: 9417504 · Received December 5, 2019

    Report

    Report Number
    2183959-2019-67938
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Date of Event
    November 1, 2019
    Report Date
    December 5, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AMS SPECTRA PENILE PROSTHESIS(SPP) DEVICE WAS DEFECTIVE. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211682 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS PROSTHESIS PENILE FAE BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1