BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACHEAL STENT

    MDR report key: 3205 · Received July 9, 1992

    Report

    Report Number
    3205
    Event Type
    Injury
    Date Received
    July 9, 1992
    Date of Event
    June 29, 1992
    Report Date
    June 30, 1992
    Manufacturer
    DUMEN
    Product Code
    MEW
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    TRACHEAL STENT WAS INSERTED ON 2/20/92. STENOSIS DIALATED UP DUE TO STENT PLACEMENT. APPROXIMATELY 6/22/92 PATIENT DEVELOPED A COUGH. STENT WAS NOTED TO BE DISPLAYED BY BRONCHOSCOPY. THE STENT WAS REMOVED AND A LARGE 14 X 30 STENT WAS REINSERTED. NO DEVICE FAILURE OCCURREDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACHEAL STENT MEW DUMEN 12MM X 30MM

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention