BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETHICON

    MDR report key: 2503 · Received February 24, 1993

    Report

    Report Number
    2503
    Event Type
    Death
    Date Received
    February 24, 1993
    Date of Event
    December 4, 1992
    Report Date
    February 3, 1993
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    GAO
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON DECEMBER 3, PATIENT HAD A CAROTID ENDARTERECTOMY. ON DECEMBER 4, PATIENT WAS BROUGHT BACK TO OR WITH A LARGE HEMATOMA OVER INCISION AREA. DURING FOLLOWING WEEK THE SURGEON STATED PATIENT DIED. DR. STATED THE SUTURE KNOTS WERE STILL TIED AND IT LOOKED AS IF THE SUTURE HAD SPLIT. MANUFACTURER TO PROVIDE QUALITY CONTROL RESULTS OF SUTURE BACK TO HOSPITALDEVICE 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: A DEVICE FROM SAME LOT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON SUTURE GAO JOHNSON & JOHNSON 8706H 6-0 PROPRENEE DKR983

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death