BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM-MADE BRONCHIAL STENT

    MDR report key: 8106 · Received March 17, 1994

    Report

    Report Number
    8106
    Event Type
    Malfunction
    Date Received
    March 17, 1994
    Date of Event
    March 9, 1994
    Report Date
    March 17, 1994
    Manufacturer
    E BENSON HOOD LABORATORIES, INC.
    Product Code
    MEW
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING PLACEMENT OF STENT, IT BECAME FOLDED IN THE BRONCHUS. ATTEMPT BEING MADE TO UNFOLD WHEN SECTION TORE OUT OF STENT. TRACHEOSTOMY WAS PERFORMED AND LARGER PORTIONS OF STENT WERE RETRIEVED. PT MAY RETURN FOR PROCEDURE AFTER OBTAINING NEW STENT. PROSTHESIS ORIGINALLY BROUGHT TO HOSP BY SURGEON (CUSTOM MADE). THE OTHER INSTRUMENTS BEING USED AT TIME OF EVENT WERE BRONCHOSCOPE AND LARYNGOSCOPE.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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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: MAYBE. CORRECTIVE ACTIONS: NO DATA. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM-MADE BRONCHIAL STENT Implant BRONCHIAL STENT MEW E BENSON HOOD LABORATORIES, INC. 09064

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other