BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 2932163 · Received January 25, 2013

    Report

    Report Number
    3003990090-2012-00087
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    April 14, 2011
    Report Date
    December 14, 2012
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    FTL
    PMA / PMN Number
    K101169
    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 PATIENT SUFFERED BODILY INJURIES. INJURIES AND OR SYMPTOMS INCLUDE INABILITY TO URINATE WITHOUT HAVING TO CATHETERIZE. PATIENT CLAIMS TO HAVE INFECTIONS ALL THE TIME AND CANNOT VOID ALL OF HER URINE; FEELING A LOT OF PAIN AN DISCOMFORT. PAINFUL INTERCOURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36098 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC. CAL-DS01 011031

    Patients

    Seq Age Sex Outcome Treatment
    1 Other