BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX PCOX 25X20CM X1

    MDR report key: 3190619 · Received June 13, 2013

    Report

    Report Number
    9615742-2013-00569
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Report Date
    May 27, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    PMA / PMN Number
    K110815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: THE MESH TORE WHEN IT WAS INSERTED AND APPLIED TO THE PT. A NEW PIECE OF MESH WAS USED. THERE WAS NO TISSUE DAMAGE, UNANTICIPATED BLOOD LOSS, UNANTICIPATED COLOSTOMY, FORMAL LAPAROTOMY, RE-OPERATION, CONVERSION TO OPEN PROCEDURE, OR EXTENDED OPERATING ROOM TIME. THIS DID NOT CAUSE MORE THAN 250 CC OF UNANTICIPATED BLOOD LOSS. THE CASE WAS NOT DELAYED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270507 PARIETEX PCOX 25X20CM X1 PARIETEX MESH OTN SOFRADIM PRODUCTION PMK00628

    Patients

    Seq Age Sex Outcome Treatment
    1