BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 4201932 · Received October 20, 2014

    Report

    Report Number
    3003990090-2014-00060
    Event Type
    Injury
    Date Received
    October 20, 2014
    Date of Event
    August 2, 2012
    Report Date
    September 26, 2014
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    FTL
    PMA / PMN Number
    K101169
    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 COMPLAINTS STATES THE PATIENT SUFFERED FROM PAIN, INFECTIONS, BOWEL PROBLEMS, AND DYSPAREUNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666821 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC. CAL-DS01 109027

    Patients

    Seq Age Sex Outcome Treatment
    1 Other