BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 4201929 · Received October 20, 2014

    Report

    Report Number
    3003990090-2014-00041
    Event Type
    Injury
    Date Received
    October 20, 2014
    Date of Event
    January 3, 2012
    Report Date
    September 24, 2014
    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 THE PATIENT SUFFERED ABDOMINAL/PELVIC PAIN, EROSION, STRESS URINARY INCONTINENCE, VAGINAL SCARRING, DYSPAREUNIA, AND BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667187 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC. CAL-DS01 102002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R