BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIEGMANN-GOFF ENDOSCOPIC LIGATOR

    MDR report key: 7110 · Received November 1, 1993

    Report

    Report Number
    32838-1993-09017
    Event Type
    Injury
    Date Received
    November 1, 1993
    Date of Event
    August 18, 1993
    Report Date
    September 20, 1993
    Manufacturer
    SUPERIOR HEALTH CARE GROUP, INC.
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN'S ASSISTANT STATES THAT ON 8/17/93 THE PATIENT PRESENTED FOR BANDING OF ESOPHAGEAL VARICES WHICH WERE NEITHER CURRENTLY BLEEDING NOR HAD BEEN PREVIOUSLY TREATED WITH SCLEROTHERAPY. AFTER THE PROCEDURE THE PATIENT COMPLAINED OF MINOR CHEST PAIN, AN ANTICIPATED SIDE EFFECT ACCORDING TO THE PHYSICIAN, AND WAS THEREFORE DISCHARGED HOME. ON 8/18/93, THE PATIENT RETURNED TO THE HOSPITAL WITH PRESISTENT CHEST PAIN AND FEVER. THE PATIENT WAS ADMITTED WITH QUESTION OF AN ESOPHAGEAL PERFORATION. X-RAYS WERE TAKEN WHICH COULD NOT CONFIRM A PERFORATION. THE PATIENT WAS PLACED ON ANTIBIOTICS AND DISCHARGED FIVE DAYS LATER IN GOOD CONDITION. THE PHYSICIAN COULD NOT VERIFY A PRODUCT FAILURE AND INCERTAIN IF THIS REACTION SHOULD HAVE BEEN AN ANTICIPATED PART OF THE PROCEDURE.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIEGMANN-GOFF ENDOSCOPIC LIGATOR SUPERIOR HEALTH CARE GROUP, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention