BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOFRADIM MESH

    MDR report key: 3252302 · Received July 23, 2013

    Report

    Report Number
    9615742-2013-00919
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    October 24, 2007
    Report Date
    July 8, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISABILITY, AND IMPAIRMENT. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341961 UNKNOWN SOFRADIM MESH SOFRADIM MESH FTL SOFRADIM PRODUCTION CVRG0102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other