BEUDAMED
    FDA Adverse Event Summary report: N

    DESARA

    MDR report key: 4201063 · Received October 20, 2014

    Report

    Report Number
    3003990090-2014-00026
    Date Received
    October 20, 2014
    Date of Event
    October 14, 2011
    Report Date
    September 24, 2014
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 THE PATIENT SUFFERED SERIOUS SIDE EFFECTS, INCLUDING, BUT NOT LIMITED TO, EROSION, MESH CONTRACTION, INFECTION, FISTULA, INFLAMMATION, SCAR TISSUE, ORGAN PERFORATION, DYSPAREUNIA (PAIN DURING SEXUAL INTERCOURSE), BLOOD LOSS, NEUROPATHIC AND OTHER ACUTE CHRONIC NERVE DAMAGE AND PAIN, PUDENDAL NERVE DAMAGE, PELVIC FLOOR DAMAGE, AND CHRONIC PELVIC PAIN, AS WELL AS OTHER SEVERE AND PERMANENT HEALTH CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667028 DESARA SURGICAL MESH OTN CALDERA MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other