BEUDAMED
    FDA Adverse Event Other Summary report: N

    SLEEK OTW

    MDR report key: 2163622 · Received June 8, 2011

    Report

    Report Number
    9616666-2011-00003
    Event Type
    Other
    Date Received
    June 8, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 7, 2011
    Manufacturer
    CLEARSTREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SLEEK OTW BALLOON WOULD NOT DEFLATE. THE PHYSICIAN WAS ABLE TO BURST THE BALLOON AND RETRIEVE. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEK OTW PTA LIT CLEARSTREAM TECHNOLOGIES, LTD. 50030584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention