BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STOP

    MDR report key: 3574543 · Received January 14, 2014

    Report

    Report Number
    3006302280-2013-00004
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    May 9, 2007
    Report Date
    December 13, 2013
    Manufacturer
    CL MEDICAL
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLAINTIFF'S LAWYER REPORTED THAT PATIENT ALLEGEDLY WAS IMPLANTED WITH A CL MEDICAL I-STOP (LOT UNKNOWN, REF. NO. UNKNOWN). PATIENT HAD ANOTHER SURGERY FOR POP. PATIENT COMPLAINED ABOUT PAIN, EROSION, ADDITIONAL SURGERIES, INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37190 I-STOP NONE FTL CL MEDICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNCLEAR - CLAIM IS REFERRING TO POP TREATMENT AND| ONLY).| THIS DEVICE AND IT'S INTENDED TO BE USED FOR SUI| ANCHORS USED ON THE I-STOP (THERE IS NO ANCHORS ON