BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN URETEX MESH PRODUCT

    MDR report key: 4210780 · Received October 29, 2014

    Report

    Report Number
    9615742-2014-00325
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 10, 2005
    Report Date
    October 8, 2014
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693776 UNKNOWN URETEX MESH PRODUCT UNKNOWN URETEX OTN SOFRADIM PRODUCTION UNKNOWN URETEX NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other