BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 2914901 · Received January 8, 2013

    Report

    Report Number
    3003990090-2012-00226
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 2, 2010
    Report Date
    December 6, 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 WAS REPORTED TO CALDERA MEDICAL BY AN ATTORNEY. LEGAL COMPLAINT STATES THAT PATIENT SUFFERED BODILY INJURIES. INJURIES AND/OR SYMPTOMS INCLUDE DISCOMFORT, PAINFUL SEXUAL INTERCOURSE, DIFFICULTY URINATING, BURNING SENSATION AND RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8705 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC. CAL-DS01 30011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other