BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERTUBE FOR LIGATOR

    MDR report key: 1370 · Received August 11, 1992

    Report

    Report Number
    32838-1992-00046
    Event Type
    Injury
    Date Received
    August 11, 1992
    Date of Event
    April 20, 1992
    Report Date
    July 28, 1992
    Manufacturer
    SUPERIOR HEALTHCARE GROUP, INC.
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 4/20/92 A MALE PATIENT PRESENTED AS AN OUTPATIENT FOR FOREIGN BODY REMOVAL FROM ESOPHAGUS. DURING PLACEMENT OF THE OVERTUBE INTO THE ESOPHAGUS THE PHYSICIAN MET RESISTANCE AT THE CRICOPHARYNGEAL JUNCTION. THE OVERTUBE WAS REMOVED AND A MUCOSAL DISECTION CREATED BY A PINCH INJURY WAS NOTED ENDOSCOPICALLY. A CHEST X-RAY AND CONTRAST SWALLOW WAS PERFORMED AND CONFIRMED THE DISSECTION AND EVIDENCE OF PNEUMOMEDIASTINUM. SURGICAL EXPLORATION WAS DONE THE SAME DAY TO DRAIN THE MEDIASTINUM AND NO FREE AIR WAS NOTED. THE PATIENT WAS HOSPITALIZED FOR APPROXIMATELY ONE WEEK AND DISCHARGED IN GOOD HEALTHINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. 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: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVERTUBE FOR LIGATOR SAME SUPERIOR HEALTHCARE GROUP, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention