BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 3012380 · Received March 7, 2013

    Report

    Report Number
    3003990090-2013-00005
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    January 3, 2011
    Report Date
    January 24, 2013
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    FTL
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 SERIOUS BODILY INJURIES, INCLUDING, BUT NOT LIMITED TO, EXTREME PAIN, VAGINAL EROSION, DYSPAREUNIA, ABDOMINAL AND PELVIC PAIN, RECURRENCE OR URINARY INCONTINENCE, ADD'L SURGERY AND/OR OTHER INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98402 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC. CAL-DS01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other