BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS 800 GU SPHINCTER PROSTHESIS

    MDR report key: 4382 · Received October 26, 1992

    Report

    Report Number
    4382
    Event Type
    Malfunction
    Date Received
    October 26, 1992
    Date of Event
    September 3, 1992
    Report Date
    October 26, 1992
    Manufacturer
    AMERICAN MEDICAL SYSTEMS - PFIZER HOSPITAL PRODUCTS GROUP
    Product Code
    FAG
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    A 87 YEAR OLD MALE PRESENTED TO MOUNT SINAI MEDICAL CENTER WITH THE FOLLOWING DIAGNOSIS: STATUS POST AMS GU SPINCTER PROSTHESIS WITH PROBABLE FLUID LOSS. HE SUBSEQUENTLY DISCHARGED IN STABLE CONDITIONINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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. 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 AMS 800 GU SPHINCTER PROSTHESIS FAG AMERICAN MEDICAL SYSTEMS - PFIZER HOSPITAL PRODUCTS GROUP 800 GU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other