BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN URETEX MESH PRODUCT

    MDR report key: 3431688 · Received October 23, 2013

    Report

    Report Number
    9615742-2013-02131
    Event Type
    Injury
    Date Received
    October 23, 2013
    Date of Event
    July 24, 2007
    Report Date
    October 10, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER).

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER).

    Description of Event or Problem · 1

    PROCEDURE: UROGYNECOLOGICAL. ACCORDING TO THE RPTR: THE PT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543937 UNKNOWN URETEX MESH PRODUCT NONE OTN SOFRADIM PRODUCTION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other