BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENILE IMPLANT

    MDR report key: 80456 · Received February 15, 1995

    Report

    Report Number
    80456
    Event Type
    Injury
    Date Received
    February 15, 1995
    Date of Event
    November 29, 1994
    Report Date
    December 30, 1994
    Manufacturer
    DACOMED
    Product Code
    FAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS 57 YR OLD MALE HISTORY OF IMPOTENCE HAD A SEMI-RIDING PENILE PROSTHESIS IMPLANTED IN 1981. HE HAS NOTED RECENTLY THAT THE RIGHT SIDE HAS NOT MAINTAINED ITS RIGIDITY AND WISHES REPLACEMENT WITH A MORE RIGID TYPE. CO IDENTIFIERS (NOT ENOUGH SPACE ALLOTTED ON FORM); DISTAL TIP: REORDER NO.:12-3D, PART NO.: 800214-003 LOT NI.: 91001H1007 1 PR. PROXIMAL TIP: RECORDER NO. 12-5P PART NO. 800114-005 LOT NO. 90050F1004 BODY: RECORDER NO. 12DPB PART NO. 800120-012 LOT NO. 90027D111. ADD'L CATALOG #:800120-012. ADD'L LOT #:900270111.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENILE IMPLANT Implant PENILE IMPLANT FAE DACOMED SEE #5 91001H1007,90050F1004

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization