BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFRADIM PRODUCT

    MDR report key: 2410814 · Received December 2, 2011

    Report

    Report Number
    1219930-2011-01046
    Event Type
    Injury
    Date Received
    December 2, 2011
    Date of Event
    January 1, 2005
    Report Date
    November 3, 2011
    Manufacturer
    UNITED STATES SURGICAL
    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). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT #(B)(4) FOR AN "UNK SOFRADIM."

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PRODUCT ALLEGEDLY ERODED FOLLOWING THE INITIAL IMPLANTATION IN 2005. PT HAS OR WILL UNDERGO CORRECTIVE SURGERIES, REMOVAL EXPECTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFRADIM PRODUCT SOFRADIM PRODUCT FTL UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R