BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-SLING

    MDR report key: 2926226 · Received January 14, 2013

    Report

    Report Number
    3003990090-2012-00086
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    February 22, 2010
    Report Date
    December 14, 2012
    Manufacturer
    HERNIAMESH S.R.L.
    Product Code
    PAH
    Adverse Event
    Yes
    Report Source
    Distributor 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 HOLD URINE, URINARY INCONTINENCE HAS BECOME WORSE; AND BLADDER INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20413 T-SLING SURGICAL MESH PAH HERNIAMESH S.R.L. T-SLING 0388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other