BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 4201933 · Received October 20, 2014

    Report

    Report Number
    3003990090-2014-00057
    Event Type
    Injury
    Date Received
    October 20, 2014
    Date of Event
    September 29, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    EVENT WAS REPORTED TO CALDERA MEDICAL BY AN ATTORNEY. IN THE LEGAL COMPLAINT THE PATIENT STATES THAT HER BLADDER GET BLOATED, SHE CANNOT URINATE COMPLETELY, SHE SUFFERS PAIN DURING SEX, SHE HAS PAIN ON AND AROUND HER CERVIX, AND SHE GETS BACTERIAL URINARY TRACT INFECTIONS THAT RECURE EVERY COUPLE OF MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666801 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC. CAL-DS01 30009

    Patients

    Seq Age Sex Outcome Treatment
    1 Other