BEUDAMED
    FDA Adverse Event Summary report: N

    UTREX PLUS PENILE IMPLANTS

    MDR report key: 9538 · Received February 7, 1994

    Report

    Report Number
    9538
    Date Received
    February 7, 1994
    Report Date
    January 31, 1994
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    FAE
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PROSTHESIS FAILED TO INFLATE AT POST-OPERATIVE CHECK DUE TO POSSIBLE FLUID LEAK.7. MODEL NO: CONNECTOR PACT - 72400099 RESIVOUR - 7240176 PREPARATEION PACK - 7240001INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTREX PLUS PENILE IMPLANTS FAE AMERICAN MEDICAL SYSTEMS SEE UNDER DESCRIPTION

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Invalid Data