BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 2871629 · Received December 7, 2012

    Report

    Report Number
    3003990090-2012-00210
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    February 21, 2012
    Report Date
    December 3, 2012
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    FTL
    PMA / PMN Number
    K101169
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 BODILY INJURIES. INJURIES AND OR SYMPTOMS INCLUDE CHRONIC VAGINAL PAIN, INFECTIONS, DISCOMFORT AND PAINFUL SEXUAL INTERCOURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC. CAL-DSO1 005044

    Patients

    Seq Age Sex Outcome Treatment
    1 Other