BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 2871606 · Received December 7, 2012

    Report

    Report Number
    3003990090-2012-00194
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    December 12, 2008
    Report Date
    November 29, 2012
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    FTL
    PMA / PMN Number
    K072456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    EVENT REPORTED BY ATTORNEY. THE LEGAL COMPLAINT STATES THAT THE PT SUFFERED BODILY INJURIES, WHICH INCLUDE STABBING, BURNING PAIN, PAINFUL SEXUAL INTERCOURSE, PAINFUL WHEN URINATING, BLEEDING AND RECURRENCE OF INCONTINENCE. PT FIRST EXPERIENCED SYMPTOMS IN (B)(6) 2008, BUT DID NOT ATTRIBUTE THEM TO THE MESH UNTIL SHE SAW THE TELEVISION COMMERCIAL IN (B)(6) 2011. PT RECEIVED EXTRACTION OF THE PELVIC MESH ON 12/17/2008. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC. CAL-DSO1 30000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other