BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN URETEX MESH PRODUCT

    MDR report key: 3955136 · Received July 22, 2014

    Report

    Report Number
    9615742-2014-00234
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    August 8, 2003
    Report Date
    July 16, 2014
    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).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PT ALLEGED INJURY. MEDICAL HISTORY: STRESS URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428729 UNKNOWN URETEX MESH PRODUCT NONE OTN SOFRADIM PRODUCTION NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other