BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STOP

    MDR report key: 4366495 · Received December 19, 2014

    Report

    Report Number
    3006302280-2014-00001
    Event Type
    Injury
    Date Received
    December 19, 2014
    Date of Event
    January 31, 2013
    Report Date
    May 29, 2014
    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

    PLAINTIFF'S LAWYER REPORTED THAT PATIENT ALLEGEDLY WAS IMPLANTED WITH A CL MEDICAL I-STOP (LOT IS-12-37, REF. IS-(B)(4)). PATIENT COMPLAINED ABOUT DYSPAREUNIA, ABDOMINAL PAIN, UTI, DYSURIA, RECURRENT SUI AND ADDITIONAL SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836780 I-STOP NONE FTL CL MEDICAL IS-5 IS-12-37

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK