BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 3012386 · Received March 7, 2013

    Report

    Report Number
    3003990090-2013-00021
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    April 15, 2009
    Report Date
    January 29, 2013
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    FTL
    PMA / PMN Number
    UNK
    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 COMPLAINT STATES THAT PT SUFFERED PAIN, EROSION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, AND VAGINAL SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98533 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC. CAL-DS01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other