BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAPHASE PENILE PROSTHESIS, CYLINDER BODUS

    MDR report key: 8120 · Received May 13, 1994

    Report

    Report Number
    8120
    Event Type
    Malfunction
    Date Received
    May 13, 1994
    Date of Event
    May 10, 1994
    Report Date
    May 13, 1994
    Manufacturer
    DACOMED CORP.
    Product Code
    FAE
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PT HAD PENILE PROSTHESIS IMPLANTED 1/24/89. RETURNED FOR REPLACEMENT DUE TO LOSS OF RIGIDITY AND POSSIBLE BROKEN WIRES. REPLACED WITH ANOTHER MODEL PENILE PROSTHESIS. MALFUNCTION PROSTHESIS CONTAINED 3 PARTS: PROXIMAL TIPS, 1 PR, REORDER #800113 LOT #87013E1003; CYLINDER BODIES, 1 PR, REORDER #800120 LOT #88048C100B; DISTAL TIPS, 1 PR, REORDER #800213-002 LOT #8701281003.DEVICE 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAPHASE PENILE PROSTHESIS, CYLINDER BODUS Implant DURAPHASE PENILE PROSTHESIS, CYLINDER BODUS FAE DACOMED CORP. 88048C1008

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other