BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 2941409 · Received January 29, 2013

    Report

    Report Number
    MW5028807
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON ESOPHAGOGASTRODUODENOSCOPY, PT WAS FOUND TO HAVE ESOPHAGEAL VARICIES. A SPEEDBAND SUPERVIEW SUPER 7 BANDING DEVICE WAS UTILIZED. THE PHYSICIAN FELT IT LEFT AN ABRASION IN THE PT'S ESOPHAGUS. THIS DID NOT REQUIRE MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39347 SPEEDBAND SUPERVIEW SUPER 7 NONE MND BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR