BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOFRADIM PRODUCT

    MDR report key: 3231625 · Received July 12, 2013

    Report

    Report Number
    9615742-2013-00791
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    November 2, 2006
    Report Date
    June 18, 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

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: STRESS UI /PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323986 UNKNOWN SOFRADIM PRODUCT SOFRADIM MESH FTL SOFRADIM PRODUCTION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other