BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFRADIM PRODUCT

    MDR report key: 2442550 · Received February 2, 2012

    Report

    Report Number
    9615742-2012-00050
    Event Type
    Injury
    Date Received
    February 2, 2012
    Date of Event
    December 19, 2012
    Report Date
    January 4, 2012
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: IT WAS REPORTED THAT THE SURGEON IMPLANTED MESH IN PATIENT FOR EPIGASTIC HERNIA. IT WAS REPORTED THAT THE SURGEON NOTED A POSSIBLE HOLE IN THE MESH AND ANOTHER PROCEDURE WAS INDICATED. THE SECOND PROCEDURE WAS PERFORMED THE WEEK OF (B)(6), 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R