BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOWER RING PEG SYSTEM

    MDR report key: 1842 · Received November 17, 1992

    Report

    Report Number
    1842
    Event Type
    Death
    Date Received
    November 17, 1992
    Date of Event
    October 7, 1992
    Report Date
    November 3, 1992
    Manufacturer
    CORPAK, INC.
    Product Code
    KGC
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A 72 YEAR OLD GENTLEMAN WHO WAS ADMITTED TO OUR INSTITUTION ON AUGUST 19, 1992. ON AUGUST 20 HE UNDERWENT A CORONARY ARTERY BYPASS (CAB) GRAFT. HE SUFFERED A CEREBRAL VASCULAR ACCIDENT SOMETIME DURING OR IMMEDIATELY AFTER HIS CAB. HIS PROGNOSIS WAS POOR. ON OCTOBER 5TH A PERCUTANEOUS ENDOSCOPIC GASTRASTOMY (PEG) TUBE WAS PLACED. IT WAS DETERMINED TO BE DISLODGED ON OCTOBER 7TH. IT WAS REMOVED AND DISCARDED. THE GENTLEMAN'S HEALTH CONTINUED TO DETERIORATE AND HE DIED ON OCTOBER 12, 1992DEVICE 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 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 DISCARDED, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOWER RING PEG SYSTEM Implant PEG KIT KGC CORPAK, INC. 30-6020 A06BH

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death