BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAVERY DILATOR 38 FR. 12.8MM

    MDR report key: 8175 · Received July 23, 1993

    Report

    Report Number
    8175
    Event Type
    Injury
    Date Received
    July 23, 1993
    Date of Event
    March 18, 1993
    Manufacturer
    WILSON - COOK
    Product Code
    EZM
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    SAVERY DILATOR USED DURING A GASTROSCOPY PROCEDURE. DILITATION WAS PERFORMED AND THE PATIENT TOLERATED THE PROCEDURE WELL. A FOLLOW UP BARIUM SWALLOW WAS DONE WHICH SHOWED A SMALL ESOPHAGEAL LEAK. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR SURGICAL CONSULT. THIS A POSSIBLE COMPLICATION OF THIS TYPE OF PROCEDURE.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVERY DILATOR 38 FR. 12.8MM SAVERY EZM WILSON - COOK UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention