BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX COMP 20X15CM W THR X1

    MDR report key: 3902260 · Received June 25, 2014

    Report

    Report Number
    9615742-2014-00217
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 5, 2014
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    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 PT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370626 PARIETEX COMP 20X15CM W THR X1 PARIETEX MESH FTL SOFRADIM PRODUCTION PHD00335

    Patients

    Seq Age Sex Outcome Treatment
    1 Other