BEUDAMED
    FDA Adverse Event Summary report: N

    1-STOP

    MDR report key: 3631554 · Received January 14, 2014

    Report

    Report Number
    3006302280-2013-00002
    Date Received
    January 14, 2014
    Date of Event
    November 30, 2010
    Report Date
    December 13, 2013
    Manufacturer
    CL MEDICAL
    Product Code
    FMG
    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 NUMBER, REF NO UNKNOWN). PATIENT HAD ANOTHER SURGERY FOR POP A YEAR AFTER. PATIENT COMPLAINED ABOUT PAIN, EROSION, ADDITIONAL SURGERIES, INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37293 1-STOP NONE FMG CL MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK