BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERTUBE-LIGATOR

    MDR report key: 1706 · Received November 9, 1992

    Report

    Report Number
    1221332-1992-00113
    Event Type
    Injury
    Date Received
    November 9, 1992
    Date of Event
    September 11, 1992
    Report Date
    September 30, 1992
    Manufacturer
    SUPERIOR HEALTH CARE GROUP, INC.
    Product Code
    FHN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR STATES THAT A 71 YEAR OLD FEMALE WITH CIRRHOSIS PRESENTED WITH GASTROINTESTINAL BLEEDING. AFTER BLEEDING SPONTANEOUSLY STOPPED, ENDOSCOPIC LIGATION WAS PERFORMED ON 9/11/92. AFTER PASSING THE ENDOSCOPE WITHOUT DIFFICULTY, RESISTANCE WAS MET AT THE CRICOPHARYNGEAL JUNCTION WHEN PASSING THE OVERTUBE. THE SCOPE AND OVERTUBE WERE REMOVED. THE SCOPE WAS PASSED AGAIN AND SCLEROTHERAPY PERFORMED. AFTER SEVERAL HOURS POST SCLEROSING, THE PATIENT COMPLAINED OF CHEST AND NECK PAIN. EXAMINATION REVEALED CREPITUS IN THE NECK TISSUE. A CHEST X-RAY SHOWED EMPHYSEMA AND A GASTGRAPHIN SWALLOW DOCUMENTED A LARGE RENT IN THE POSTERIOR CRICOPHARYNGEUS WITH ACCUMULATED FLUID. THE PATIENT HAD PENROSE DRAINS PLACED SURGICALLY AND WAS PLACED ON ANTIBIOTICS. THE PATIENT REMAINS HOSPITALIZED AT MUHLENBERG MC AMD IS GRADUALLY IMPROVINGINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER 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: 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 OVERTUBE-LIGATOR FHN SUPERIOR HEALTH CARE GROUP, INC. 200219

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention