BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STOP

    MDR report key: 3653279 · Received January 6, 2014

    Report

    Report Number
    3006302280-2012-00001
    Event Type
    Injury
    Date Received
    January 6, 2014
    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 IS-5). NO ADDITIONAL INFO WAS PROVIDED REGARDING THE EVENT OR PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5180 I-STOP NONE FTL CL MEDICAL IS-5 IS-11-33

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention APICAL| AMS ELEVATE ANTERIOR