BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROLAC

    MDR report key: 7094729 · Received December 7, 2017

    Report

    Report Number
    3004504732-2017-00003
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 10, 2017
    Manufacturer
    POLYGANICS INNOVATIONS BV
    Product Code
    JXI
    PMA / PMN Number
    K050573
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL SURGERY ON (B)(6) 2017: NEUROLYSIS ON THE RIGHT MEDIAN NERVE. EARLY (B)(6) 2017 THE PATIENT RETURNED TO THE SURGEON WITH COMPLAINTS OF REDNESS AND SWELLING. PATIENT WAS REQUESTED TO COOL THE SITE AND WAS SUBSCRIBED ANTIBIOTICS. ON (B)(6) THE PATIENT RETURNED TO THE SURGEON WHO OBSERVED TOO LITTLE IMPROVEMENT UPON WHICH SHE DECIDED TO DO A SURGERY ON (B)(6) BY OPENING THE WOUND AND RINSE THE SITE.

    Description of Event or Problem · 1

    APPROXIMATELY 3,5 MONTHS AFTER SURGERY THE PATIENT DEVELOPED A SWELLING AT THE SITE OF IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877500 NEUROLAC NERVE CUFF JXI POLYGANICS INNOVATIONS BV NEUROLAC 6.0 MM NGA2015101511

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention