BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 4201931 · Received October 20, 2014

    Report

    Report Number
    3003990090-2014-00061
    Event Type
    Injury
    Date Received
    October 20, 2014
    Date of Event
    October 18, 2010
    Report Date
    September 26, 2014
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    FTL
    PMA / PMN Number
    K072456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    EVENT WAS REPORTED TO CALDERA MEDICAL BY AN ATTORNEY. LEGAL COMPLAINT STATES THE PATIENT SUFFERED WEAKNESS IN LEFT LEG, INABILITY TO MOVE HER LEFT SIDE FROM THE WAIST DOWN, PAIN, DYSPAREUNIA, RECURRENT INCONTINENCE, INFECTIONS AND DEPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667951 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC. CAL-DS01 30008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R