BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENATECH - FEMORAL FILTER SYSTEM

    MDR report key: 4831 · Received July 8, 1992

    Report

    Report Number
    4831
    Event Type
    Malfunction
    Date Received
    July 8, 1992
    Report Date
    July 7, 1992
    Manufacturer
    VENATECH CORPORATION
    Product Code
    JRL
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    FILTER MIGRATED AND CANNOT BE RETREIVED. FURTHER MIGRATION COULD CAUSE DEATHINVALID 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 VENATECH - FEMORAL FILTER SYSTEM JRL VENATECH CORPORATION PATENT NO. 31327

    Patients

    Seq Age Sex Outcome Treatment
    1 Other