BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-SLING

    MDR report key: 3012358 · Received March 7, 2013

    Report

    Report Number
    3003990090-2013-00050
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    September 7, 2006
    Report Date
    February 19, 2013
    Manufacturer
    HERNIAMESH S.R.L.
    Product Code
    PAH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, 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 SIGNIFICANT HARM, CONSCIOUS PAIN, AND SUFFERING, PHYSICAL INJURY AND BODILY IMPAIRMENT RESULTING PERMANENT PHYSICAL DEFICITS, PERMANENT AND OTHER SEQUELAE LIKELY TO CONTINUE MANIFESTING IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98337 T-SLING SURGICAL MESH PAH HERNIAMESH S.R.L. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other