BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBICOR PENILE PROSTHESIS

    MDR report key: 54830 · Received December 6, 1996

    Report

    Report Number
    2126328-1996-05695
    Event Type
    Injury
    Date Received
    December 6, 1996
    Date of Event
    November 4, 1996
    Report Date
    December 6, 1996
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP PERFORMED WITHIN SPECIFICATIONS. CYLINDER PERFORMED WITHIN SPECIFICATIONS. CYLINDER HAD OR DAMAGE.

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED DUE TO FLUID LOSS. REFER TO FDA ACCESS#1010326.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBICOR PENILE PROSTHESIS Implant APP FHW AMERICAN MEDICAL SYSTEMS, INC. APP BC691 001,BC691 001,BC691 001

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R