BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX PCOX 25X20CM X1

    MDR report key: 3924693 · Received June 25, 2014

    Report

    Report Number
    9615742-2014-00216
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 19, 2014
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    PMA / PMN Number
    K110815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP VENTRAL HERNIA ; ACCORDING TO THE REPORTER: THE MESH TORE ON THE SUTURE LINE AFTER IT WAS IMPLANTED. MESH WAS REMOVED AND ANOTHER PIECE WAS IMPLANTED. PATIENT WAS KEPT UNDER ANESTHESIA FOR AN EXTENDED PERIOD OF TIME BECAUSE OF THIS INCIDENT. HERNIA DEFECT WAS FINALLY REPAIRED WITH AN ADDITIONAL PIECE OF MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369824 PARIETEX PCOX 25X20CM X1 PARIETEX MESH OTN SOFRADIM PRODUCTION PNG0672X

    Patients

    Seq Age Sex Outcome Treatment
    1