BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCO VENTRAL PATCH 6C

    MDR report key: 3761147 · Received December 31, 2013

    Report

    Report Number
    9615742-2013-02528
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    November 8, 2013
    Report Date
    December 12, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    PMA / PMN Number
    K120506
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: A COVIDIEN STUDY IDENTIFIED A PT THAT HAD A HERNIA REPAIR ON (B)(6) 2013. PRESENTED WITH POS-OP PAIN ON (B)(6) 2013, WITH AN NRS SCORE OF 09/10. PAIN MEDICATION WAS ADMINISTERED, AND PAIN RESOLVED ON (B)(6) 2013. ACCORDING TO THE REPORTER, THERE IS A POSSIBLE RELATIONSHIP TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682616 PCO VENTRAL PATCH 6C PARIETEX MESH OTN SOFRADIM PRODUCTION PNC0435

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR