BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-SLING

    MDR report key: 2933269 · Received January 25, 2013

    Report

    Report Number
    3003990090-2012-00232
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    September 12, 2007
    Report Date
    December 11, 2012
    Manufacturer
    HERNIAMESH S.R.L.
    Product Code
    FTM
    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 PATIENT SUFFERED BODILY INJURIES. INJURIES AND OR SYMPTOMS INCLUDE RECURRENCE OF INCONTINENCE, PAINFUL PHYSICAL ACTIVITY, FOUL ODOR, CHRONIC PAIN, BLADDER SPASMS AND PAINFUL SEXUAL INTERCOURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36216 T-SLING SURGICAL MESH FTM HERNIAMESH S.R.L. T-SLING 0399

    Patients

    Seq Age Sex Outcome Treatment
    1 Other