BEUDAMED
    FDA Adverse Event Summary report: N

    SAEED

    MDR report key: 3070285 · Received April 15, 2013

    Report

    Report Number
    3070285
    Date Received
    April 15, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    AT END OF EGD (ESOPHAGOGASTRODUODENOSCOPY) WITH BANDING, UPON REMOVAL OF SCOPE, THE PLASTIC BANDING DEVICE BECAME DISLODGED AS PATIENT WAS HAVING BRONCHIAL SPASMS. ANESTHESIA REMOVED DEVICE NEXT TO VOCAL CORDS, PT INTUBATED BY ANESTHESIA AND TRANSFER TO PACU.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BANDING VARICES EGD.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161554 SAEED LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC * 3232539

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR ENDOSCOPE