BEUDAMED
    FDA Adverse Event Summary report: N

    BALLOON

    MDR report key: 2150416 · Received June 21, 2011

    Report

    Report Number
    2150416
    Date Received
    June 21, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    AN INPATIENT ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS BEING DILATED USING A BALLOON DILATOR AND THE BALLOON BURST. THE MANUFACTURER RESPONSE FOR THE BALLOON DILATOR, BALLOON WAS THEY SENT A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLOON BALLOON DILATOR KNQ BOSTON SCIENTIFIC * 13991591

    Patients

    Seq Age Sex Outcome Treatment
    1 *