BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 3012384 · Received March 7, 2013

    Report

    Report Number
    3003990090-2012-00216
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    October 13, 2008
    Report Date
    December 4, 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 ABDOMINAL PAIN, DISCOMFORT, AND RECURRENCE OF INCONTINENCE, CHRONIC VAGINAL PAIN AND PAINFUL SEXUAL INTERCOURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98398 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC. CAL-DS01 20161

    Patients

    Seq Age Sex Outcome Treatment
    1 Other