BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-FLATE SELF CONTAINED PENILE PROSTHESIS

    MDR report key: 1881 · Received November 20, 1992

    Report

    Report Number
    1881
    Event Type
    Malfunction
    Date Received
    November 20, 1992
    Date of Event
    October 21, 1992
    Report Date
    November 10, 1992
    Manufacturer
    UNKNOWN
    Product Code
    FAE
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE LEFT SIDE OF THE PENILE PROSTHESIS FAILED MECHANICALLY. THE PATIENT'S ERECTIONS WERE UNSUITABLE FOR INTERCOURSE. THE PROSTHESIS WAS REMOVED ON OCTOBER 21, 1992 AND REPLACED WITH DYNA-FLEX SELF CONTAINED INFLATABLE PENILE PROSTHESISINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXI-FLATE SELF CONTAINED PENILE PROSTHESIS Implant PENILE PROSTHESIS FAE UNKNOWN UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other