BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX PROGRIP PRECUT W/FLAP LEFT SIDE

    MDR report key: 1646865 · Received March 26, 2010

    Report

    Report Number
    9615742-2010-00006
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Report Date
    March 3, 2010
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K081050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT SENT: 03/24/2010.

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: THE MESH WAS TORN DURING MANIPULATION (BEFORE IMPLANTATION OR CONTACT WITH PT). IT SEEMED THE FLAP WAS FIXED TO THE REST OF THE MESH. SO BY TEARING, THE FLAP GAVE LOOSE. ANOTHER DEVICE WAS USED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX PROGRIP PRECUT W/FLAP LEFT SIDE SOFRADIM MESH FTL SOFRADIM PRODUCTION SIJ00063

    Patients

    Seq Age Sex Outcome Treatment
    1