BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 3260910 · Received July 23, 2013

    Report

    Report Number
    3003990090-2013-00261
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 22, 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 PT SUFFERED EXCRUCIATING PAIN, LACERATION OF AND DAMAGE TO INTERNAL BODILY TISSUE AND ORGANS, EROSION, ABRASION AND GRAFTING OF INTERNAL BODILY TISSUE AND ORGANS, DYSPAREUNIA, DYSURIA, SEVERE EDEMA, BLEEDING, PERMANENT SCARRING, PERMANENT BODILY IMPAIRMENT AND RELATED SEQUELAE. AS WELL AS EXTREME PAIN AND SUFFERING, PERMANENT BODILY IMPAIRMENT, MENTAL ANGUISH, LOSS OF ENJOYMENT OF LIFE, GENERAL DAMAGES AND SPECIAL DAMAGES. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342182 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other