BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCO VENTRAL PATCH 6C

    MDR report key: 3851205 · Received March 24, 2014

    Report

    Report Number
    9615742-2014-00119
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 24, 2014
    Report Date
    March 6, 2014
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K120506
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: ON (B)(6) 2014, THE PATIENT HAD THE MESH IMPLANTED. ON (B)(6) 2014, THE PATIENT REPORTED EXPERIENCING POSTOPERATIVE PAIN. THE PAIN WAS TREATED WITH MEDICATION AND NOTED TO BE RESOLVED ON (B)(6) 2014. ACCORDING TO THE PRINCIPAL INVESTIGATOR, THERE IS A POSSIBLE RELATIONSHIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172525 PCO VENTRAL PATCH 6C PARIETEX MESH FTL SOFRADIM PRODUCTION RNE9999

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR