BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STOP

    MDR report key: 3574569 · Received January 14, 2014

    Report

    Report Number
    3006302280-2013-00008
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    March 31, 2011
    Report Date
    December 30, 2013
    Manufacturer
    CL MEDICAL
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, 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). PLAINTIFF HAS BEEN IMPLANTED THE SAME DAY WITH A POP DEVICE. PLAINTIFF COMPLAINED ABOUT BLEEDING AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36790 I-STOP NONE FTL CL MEDICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BOSTON SCIENTIFIC REPLIFORM MESH TO TREAT PELVIC| AND RECTOCELE| ORGAN PROLAPSE, INCLUDING CYSTOCELE, ENTEROCELE