BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 2926267 · Received January 14, 2013

    Report

    Report Number
    3003990090-2012-00244
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    May 10, 2011
    Report Date
    December 14, 2012
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    FTL
    PMA / PMN Number
    UNK
    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 ISCHEMIC COLON AN URINARY INCONTINENCE, INTERNAL BLEEDING, LOWER ABDOMINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20234 DESARA SURGICAL MESH FTL CALDERA MEDICAL, INC. CAL-DS01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other