BEUDAMED
    FDA Adverse Event Death Summary report: N

    6-0 PROLENE

    MDR report key: 397 · Received April 16, 1992

    Report

    Report Number
    397
    Event Type
    Death
    Date Received
    April 16, 1992
    Date of Event
    March 19, 1992
    Report Date
    March 27, 1992
    Manufacturer
    ETHICON
    Product Code
    GAN
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD OPEN SURGERY WITH FIVE CORONARY BYPASSES. APPROXIMATELY 47 MINUTES AFTER SURGERY PATIENT STARTED TO HEMORRAGE. WAS RETURNED TO SURGERY (52 MINUTES AFTER END OF #1 PROCEDURE) WHERE SURGEON DETERMINED A SUTURE HAD BROKEN AT LAD GRAFT PROXIMAL ANASTOMOSIS. UNABLE TO GET PATIENT OFF PUMP. EXPIREDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT, DEVICE UNAVAILABLE FOR FOLLOW-UP INVESTIGATION EXAMINATION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6-0 PROLENE Implant N/A GAN ETHICON N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death