BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURAGEN NERVE GUIDE 6MM ID X 3CM LENGTH

    MDR report key: 5761264 · Received June 30, 2016

    Report

    Report Number
    1121308-2016-00013
    Event Type
    Injury
    Date Received
    June 30, 2016
    Date of Event
    June 8, 2016
    Report Date
    June 10, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    JXI
    PMA / PMN Number
    K011168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 01/20/2017. THE INVESTIGATION ACTIVITIES INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: THE FINISHED GOODS LOT 1141379, CATALOG PNG630 ¿ (B)(4), WAS MANUFACTURED ON 04/07/14 AND ITS EXPIRATION DATE WAS 2016-04. THE REPORTED FINISHED GOODS PRODUCT LOT ASSOCIATED WITH THIS COMPLAINT IS NEURAGEN NERVE GUIDE LOT # 1141379 (ANASCO LOT) FOR WHICH THE CORRESPONDING CMC PLAINSBORO LOT# IS 105000300232. THIS PRODUCT LOT STEMS FROM THE DISPERSION LOT 105000300231. ALL TESTING MET REQUIREMENTS, AND WERE ACCEPTABLE. ZERO COMPLAINT OF THE SAME NATURE HAVE BEEN RECEIVED FOR THE PAST YEAR (0 COMPLAINT / PRODUCT USES). THIS IS NOT STATISTICALLY ADVERSE WHEN COMPARED TO THE COMPLAINT RATE FOR THE PRIOR TIME PERIOD (0 COMPLAINT / PRODUCT USES). CONCLUSION: BASED ON THE INVESTIGATION PERFORMED BY INTEGRA, THE COMPLAINT REPORTED BY THE EUROPEAN HOSPITAL OF MARSEILLE IS NOT CONFIRMED. AS PER THE CONSIGNMENT CONTRACT SIGNED BETWEEN THE CUSTOMER AND INTEGRA, THIS IS THE RESPONSIBILITY OF THE CUSTOMER TO MANAGE EXPIRY DATES. MOREOVER, REGARDLESS OF THE CONTRACT, THIS IS THE RESPONSIBILITY OF THE HOSPITAL TO CHECK THE IMPLANT (EXPIRY DATE INCLUDED) BEFORE IMPLANTING IT INTO THE PATIENT.

    Description of Event or Problem · 1

    IT IS REPORTED A DEVICE IN CONSIGNMENT WAS USED ON (B)(6) 2016 BUT THE DEVICE IMPLANTED HAD AN EXPIRY DATE OF 30APR2016. NO PATIENT IMPACT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417776 NEURAGEN NERVE GUIDE 6MM ID X 3CM LENGTH NEURAGEN JXI INTEGRA LIFESCIENCES CORPORATION 1141379

    Patients

    Seq Age Sex Outcome Treatment
    1 Other