BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFRADIM PRODUCT

    MDR report key: 2572831 · Received May 3, 2012

    Report

    Report Number
    9615742-2012-00154
    Event Type
    Injury
    Date Received
    May 3, 2012
    Report Date
    October 4, 2018
    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). MDR REF #: 9615742-2012-00153 (URETEX TO). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT #(B)(4) FOR AN "UNKNOWN SOFRADIM".

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE AND WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R