BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM GREENFIELD FILTER

    MDR report key: 650 · Received June 2, 1992

    Report

    Report Number
    650
    Event Type
    Malfunction
    Date Received
    June 2, 1992
    Date of Event
    May 7, 1992
    Manufacturer
    MEDITECH
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    5/7/92 - PATIENT TO OR FOR GREENFIELD FILTER INSERTATION, SURGEON NOTED FILTER DID NOT COMPLETELY OPEN. PATIENT WAS RETURNED TO THE OR FOR A SECOND FILTER PLACEMENT. 1ST SITE (R) JUGULAR VEIN - 2ND SITE (R) FEMOROL VEIN. DEVICE REMAINS IN PATIENT AND MANUFACTURER WAS NOTIFIED OF EVENT.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO 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 TITANIUM GREENFIELD FILTER Implant UNKNOWN DTK MEDITECH UNKNOWN 48050

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other