BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIAL JAW

    MDR report key: 165 · Received January 28, 1992

    Report

    Report Number
    165
    Event Type
    Death
    Date Received
    January 28, 1992
    Date of Event
    December 31, 1991
    Report Date
    January 14, 1992
    Manufacturer
    MICROVASIVE
    Product Code
    HTD
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED AT 2209. SHE HAD BEEN ON NAPROSYN ANTI-INFLAMMATORY MEDICATION SINCE AUGUST. FIVE DAYS PRIOR TO ADMISSION SHE HAD BECOME NAUSEA. THE NAPROSYN HAD BEEN DISCONTINUED AND ZANTAC STARTED. THE DAY OF ADMISSION SHE HAD A LARGE BRIGHT RED STOOL WITH COFFEE GROUND MATERIAL ASPIRATED FROM THE STOMACH. A GASTROINTESTINAL CONSULTANT WAS CALLED IN. ON 12/31 AT 1330 AN ESOPHAGOGASTRODUODENOSCOPY WAS PERFORMED WITH A BIOPSY AND POSSIBLE ULCERATION TREATED WITH HEATER PROBE. PATIENT HAD TO LIE WITH RIF-GHT SIDE DOWN BECAUSE OF HER SCOLIOSIS. 5 MG OF INTRAVENOUS VERSED WAS GIVEN PRIOR TO HURRICANE SPAY OF THE OROPHARYNX. EKG REMAINED UNCHANGED WITH MULTIPLE PVC'S NOTED, AND GI M.D. WAS AWARE. POSTOPERATIVE DIAGNOSIS: SEVERE EROSIVE DUODENITIS OF THE SECOND PORTION OF THE BULB, POSSIBLE ULCERATION IN THIS AREA. AT 1650, PATIENT WAS VEERY DYSPNEIC AND UNCOMFORTABLE WITH ABDOMINAL DISTENSION AND PAIN. AN ABDOMINAL SERIES WAS OBTAINED WHICH NOTED MASSIVE FREE INTRA-ABDOMINAL AIR. CHEST X-RAY SHOWED FREE AIR UNDER THE DIAPHRAGM. THE PATIENT WAS RETURNED TO SURGERY AT 1850 ON 12/31/91 FOR AN EXPLORATORY LAPAROTOMY, CLOSURE OF PERFORATION OF DUODENUM, PERFORMED BY A GENERAL SURGEON. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO RECOVERY AT 2020 IN FAIR CONDITION ON A VENTILATOR.A SWAN GANZ CATHETER WAS INSERTED AT 0830 ON 1/1/92. THE PATIENT'S FATHER WANTED A DNR (DO NOT RESUSCITATE) BASED ON HIS KNOWLEDGE OF HIS DAUGHTER. PATIENT PRONOUNCED DEAD AT 0115 ON 1/2/92. NO AUTOPSY DONE. DEVICE WILL BE TESTED BY INDEPENDENT EVALUATOR AS WELL AS BY THE MANUFACTURER.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE NOT SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. 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: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW FORCEPS HTD MICROVASIVE UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death