BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOFRADIM PRODUCT

    MDR report key: 3220937 · Received July 3, 2013

    Report

    Report Number
    9615742-2013-00720
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    December 4, 2006
    Report Date
    June 10, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303555 UNKNOWN SOFRADIM PRODUCT SOFRADIM MESH FTL SOFRADIM PRODUCTION SG100044

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other