BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-SLING

    MDR report key: 3012351 · Received March 7, 2013

    Report

    Report Number
    3003990090-2012-00222
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    March 16, 2007
    Report Date
    December 5, 2012
    Manufacturer
    HERNIAMESH S.R.L.
    Product Code
    PAH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, 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 BODILY INJURIES. INJURIES AND OR SYMPTOMS INCLUDE RECURRENCE OF STRESS URINARY INCONTINENCE, PAINFUL SEXUAL INTERCOURSE, INFECTIONS, CHRONIC PAIN AND EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98440 T-SLING SURGICAL MESH PAH HERNIAMESH S.R.L. T-SLING 0365

    Patients

    Seq Age Sex Outcome Treatment
    1 Other