BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 3260976 · Received July 23, 2013

    Report

    Report Number
    3003990090-2013-00191
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    August 28, 2009
    Report Date
    July 17, 2013
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    FTL
    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 PATIENT SUFFERED SERIOUS BODILY INJURIES, INCLUDING, BUT NOT LIMITED TO, EXTREME PAIN, VAGINAL EROSION, DYSPAREUNIA, ABDOMINAL AND PELVIC PAIN, RECURRENCE OF URINARY INCONTINENCE AND/OR OTHER INJURIES, AS WELL AS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS REQUIRED MEDICAL TREATMENT INCLUDING ADDITIONAL SURGERIES, AND HAS SUSTAINED PERMANENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342265 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other