BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX COMP 30X20CM W THR X1

    MDR report key: 3143157 · Received May 24, 2013

    Report

    Report Number
    9615742-2013-00478
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 3, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    110815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE COLLAGEN FILM BROKE DOWN AFTER A FEW SECONDS. ABSORBATACK FIXATION AND TACKS DROPPED OFF FROM PCO MESH. (TACKS WERE NOT APPLIED ON THE EDGE). FURTHER, THE ATTACHED FIXATION SUTURES WERE ALSO DETACHED FROM THE MESH WHILE THE SURGEON WAS KNOTTING FOR FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232594 PARIETEX COMP 30X20CM W THR X1 PARIETEX COMPOSITE MESH FTL SOFRADIM PRODUCTION PKD00042

    Patients

    Seq Age Sex Outcome Treatment
    1