BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 2992145 · Received February 28, 2013

    Report

    Report Number
    3003990090-2012-00120
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    April 22, 2011
    Report Date
    January 16, 2013
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    FTL
    PMA / PMN Number
    K101169
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    EVENT WAS REPORTED TO CALDERA MEDICAL BY AN ATTORNEY. LEGAL COMPLAINT STATES THAT PATIENT SUFFERED PAIN, EROSION, URINARY PROBLEMS, FISTULA, RECURRENCE, DYSPAREUNIA, AND VAGINAL SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87234 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC. DESARA 011031

    Patients

    Seq Age Sex Outcome Treatment
    1 Other