BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILSON COOK ESOPHAGEAL BALLOON DILATOR

    MDR report key: 2071387 · Received April 21, 2011

    Report

    Report Number
    MW5020369
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 21, 2011
    Manufacturer
    WILSON COOK
    Product Code
    KNQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A BALLOON DILATOR USED IN AN ENDOSCOPY PROCEDURE FAILED TO INFLATE AND LEAKED OUT WATER. IT WAS REMOVED AND A DIFFERENT DILATOR USED. NO HARM TO THE PT. REP TO BE INFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILSON COOK ESOPHAGEAL BALLOON DILATOR BALLOON DILATOR KNQ WILSON COOK 25403

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Disability