BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON

    MDR report key: 4931 · Received June 30, 1992

    Report

    Report Number
    4931
    Event Type
    Injury
    Date Received
    June 30, 1992
    Date of Event
    June 26, 1992
    Report Date
    June 30, 1992
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    FBQ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT SCHEDULE FOR LAPROSCOPY TUBAL LIGATION. DURING LAPAROSCOPY PATIENT BEGAN BLEEDING IN ABDOMEN. MINI LAPAROSCOPY PERFORMED - PATIENT BLEEDING HEAVILY. VASCULAR SURGEONS TO OR. LAPAROSTOMY DONE FOR HEMKOSTASIS. PATIENT RECEIVED FOUR UNITS RBC'S ONE UNIT FFP. PATIENT TO ICUDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NO DATA. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDOPATH DISPOSABLE SURGICAL TROCAR FBQ JOHNSON & JOHNSON R0708 CK 3519

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention