BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEK OTW

    MDR report key: 4379972 · Received December 2, 2014

    Report

    Report Number
    9616666-2014-00015
    Event Type
    Injury
    Date Received
    December 2, 2014
    Date of Event
    November 21, 2014
    Report Date
    November 24, 2014
    Manufacturer
    CLEAR STREAM TECHNOLOGIES LTD.
    Product Code
    DQY
    PMA / PMN Number
    K102035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT EXPECTED TO BE RETURNED. THE INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE FOR 20 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779286 SLEEK OTW L11 DQY CLEAR STREAM TECHNOLOGIES LTD. 50054198

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention