BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STOP

    MDR report key: 5744407 · Received February 6, 2013

    Report

    Report Number
    3006302280-2013-00001
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    October 11, 2011
    Report Date
    January 14, 2013
    Manufacturer
    CL MEDICAL
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLAINTIFF'S LAWYER REPORTED THAT PT ALLEGEDLY WAS IMPLANTED WITH AN AMS ELEVATE ANTERIOR AND APICAL (LOT NO. UNK AND REF. NO. UNK) AND ALSO A CL MEDICAL I-STOP (LOT NO. IS-11-33, REF. NO. (B)(4)). NO ADDITIONAL INFO WAS PROVIDED REGARDING THE EVENT OR PROBLEM. AT THE TIME OF THE EVENT, THIS ADVERSE EVENT WAS NOT REPORTED BECAUSE IT ARISES FROM A LAWSUIT, WHICH WAS SUBSEQUENTLY VOLUNTARILY DISMISSED AS AGAINST CL MEDICAL. THIS REPORT IS RETROSPECTIVELY ADDRESSING THE MEDICAL DEVICE REPORTING CRITERIA. IT IS LOGGED AS A 30-DAY REPORT BUT THE TIMELINES FOR THIS REPORT ARE EXCEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52083 I-STOP NONE FTL CL MEDICAL IS-5 IS-11-33

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention