BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX PCOX SKIRT 15X10CM X1

    MDR report key: 3966212 · Received June 4, 2014

    Report

    Report Number
    9615742-2014-00209
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K110815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING INFO: (B)(4).

    Description of Event or Problem · 1

    THE COLLAGEN FILM OF THE MESH WAS DAMAGED OUT OF PACKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325642 PARIETEX PCOX SKIRT 15X10CM X1 NONE FTL SOFRADIM PRODUCTION PND0317

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR