BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STOP

    MDR report key: 3653280 · Received January 6, 2014

    Report

    Report Number
    3006302280-2012-00002
    Event Type
    Injury
    Date Received
    January 6, 2014
    Date of Event
    September 14, 2010
    Report Date
    January 14, 2013
    Manufacturer
    CL MEDICAL
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLAINTIFFS' LAWYER REPORTED THAT PT ALLEGEDLY WAS IMPLANTED WITH A CL MEDICAL I-STOP (LOT NO IS-10-24, REF NO IS-(B)(4)). PT COMPLAINED ABOUT INFECTION, EXTREME PELVIC PAIN, HARDENING OF THE MESH, EXTRUSION AND EROSION OF THE MESH, BLEEDING, PAIN DURING INTERCOURSE. PATIENT CLAIMS TO HAVE BEEN TWO SURGERIES ON (B)(6) 2011, TO REMOVE THE I-STOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5236 I-STOP NONE FTL CL MEDICAL IS-5 IS-10-24

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention NOT SURE, MAYBE MESH FOR PROLAPSE