BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAPHASE (PENILE PROSTHESIS)

    MDR report key: 4094 · Received January 6, 1993

    Report

    Report Number
    4094
    Event Type
    Injury
    Date Received
    January 6, 1993
    Date of Event
    October 13, 1992
    Report Date
    October 27, 1992
    Manufacturer
    DACOMED
    Product Code
    FAE
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURAPHASE PROSTHESIS INSERTED ON OCTOBER 13, 1992. OCTOBER 14, 1992 A.M. GLANS PENIS NOTED TO BE PURPOEL BANDAGE REMOVED. OCTOBER 16, 1992, PATIENT RETURNED TO SURGERY TO HAVE IMPLANT REMOVED. OCTOBER 25, 1992 MOST OF GLANS DRY AND HARDDEVICE NOT 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: DEVICE DISCARDED - UNABLE TO FOLLOW-UP. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAPHASE (PENILE PROSTHESIS) Implant FAE DACOMED PROS.92001C1007,ACC.91050G1001

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention