BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESARA

    MDR report key: 3012395 · Received March 7, 2013

    Report

    Report Number
    3003990090-2012-00229
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    April 21, 2008
    Report Date
    December 6, 2012
    Manufacturer
    CALDERA MEDICAL, INC.
    Product Code
    PAH
    PMA / PMN Number
    K101169
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 RECURRENCE OF INCONTINENCE, PAINFUL SEXUAL INTERCOURSE, INFECTIONS, CHRONIC ABDOMINAL PAIN, AND PAIN WHEN SITTING ON HARD SURFACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98450 DESARA SURGICAL MESH PAH CALDERA MEDICAL, INC. CAL-DS01 19452-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other