BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 4201048 · Received October 20, 2014

    Report

    Report Number
    3003990090-2014-00014
    Event Type
    Injury
    Date Received
    October 20, 2014
    Report Date
    September 23, 2014
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    OTN
    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 F AND DAMAGE TO INTERNAL BODILY TISSUE AND ORGANS, EROSION, ABRASION AND GRATING OF INTERNAL BODILY TISSUE AND ORGANS, DYSPAREUNIA, DYSURIA, SEVERE EDEMA, BLEEDING, PERMANENT SCARRING, PERMANENT BODILY IMPAIRMENT AND RELATED SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667115 DESARA SURGICAL MESH OTN CALDERA MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other