BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 2992144 · Received February 28, 2013

    Report

    Report Number
    3003990090-2012-00121
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    March 31, 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, URINARY PROBLEMS, RECURRENCE, AND STIFFENING OF VAGINAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87152 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC. DESARA 008015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other