BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACO VENTRAL PATCH 4 C

    MDR report key: 3987856 · Received May 19, 2014

    Report

    Report Number
    9615742-2014-00171
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OXJ
    PMA / PMN Number
    K120506
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    UMBILICAL HERNIA. MESH RIPPED. EXPANDER RING BROKE DURING IMPLANTATION. NO INJURY TO THE PT. DID NOT ADD EXCESSIVE TIME TO THE PROCEDURE. THE ISSUE WAS RESOLVED BY OPENING A FRESH UNIT. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297710 PACO VENTRAL PATCH 4 C PCO VENTRAL PATCH OXJ SOFRADIM PRODUCTION PNI0214

    Patients

    Seq Age Sex Outcome Treatment
    1