BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-FLATE 1000 (13 X 1400 MM)

    MDR report key: 3805 · Received July 10, 1992

    Report

    Report Number
    3805
    Event Type
    Malfunction
    Date Received
    July 10, 1992
    Date of Event
    March 10, 1992
    Manufacturer
    SURGITEK
    Product Code
    FAE
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT ENCOUNTERED DIFFICULTY WITH OPERATION OF UNI-FLATE PENILE PROSTHESIS WHICH APPAARENTLY MALFUNCTIONED. IT WAS INITIALLY IMPLANTED ON 4/29/91. PATIENT UNDERWENT SURGERY ON 3/10/92 TO REMOVE OLD IMPLANT. IT WASD REPLACED WITH AN AMS DYNAFLEX PENILE PROSTHESIS. OLD PROSTHESIS WAS KEPT AND IS TO BE SENT TO MANUFACTURER FOR INSPECTIONDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT 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: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNI-FLATE 1000 (13 X 1400 MM) Implant PENILE IMPLANT FAE SURGITEK UF169-90H

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other