BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA SLING

    MDR report key: 2871564 · Received December 7, 2012

    Report

    Report Number
    3003990090-2012-00162
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    October 2, 2009
    Report Date
    November 6, 2012
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    FTL
    PMA / PMN Number
    K101169
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 AFTER, AND AS A RESULT OF THE IMPLANTATION OF THE PRODUCTS, PLAINTIFFS SUFFERED SERIOUS BODILY INJURIES, INCLUDING BUT NOT LIMITED TO, EXTREME PAIN, EROSION OF THEIR INTERNAL BODILY TISSUE, DYSPAREUNIA, PAINFUL SCARRING, AND OTHER INJURIES. DESARA SLING IMPLANTED ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DESARA SLING SURGICAL MESH FTL CALDERA MEDICAL, INC. DESARA SLING 20862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other