BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP 15X10CM X1

    MDR report key: 3955100 · Received July 22, 2014

    Report

    Report Number
    9615742-2014-00233
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    December 22, 2015
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K051503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428744 PARIETEX UGYTEX PP 15X10CM X1 MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other