BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURAGEN NERVE GUIDE 6MM ID X 3CM LENGTH

    MDR report key: 6224882 · Received January 5, 2017

    Report

    Report Number
    1121308-2016-00023
    Event Type
    Injury
    Date Received
    January 5, 2017
    Date of Event
    December 16, 2016
    Report Date
    December 19, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    JXI
    PMA / PMN Number
    K011168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON JANUARY 20, 2017. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: THE UNIT WILL NOT BE RETURNED SINCE IT WAS IMPLANTED IN THE PATIENT. DHR REVIEW; TEN (10) RETAIN SAMPLE UNITS WERE VISUALLY INSPECTED FOR PRODUCT AND PACKAGING APPEARANCE, INCLUDING LABELING. NO ANOMALIES WERE OBSERVED. ALL UNITS MET PRODUCT AND PACKAGING SPECIFICATIONS ACCORDING TO ¿PACKAGED COLLAGEN PRODUCT INSPECTION¿. COMPLAINTS HISTORY; NO SIMILAR COMPLAINTS RELATED TO ¿EXPIRED PRODUCT IMPLANTED¿ HAVE BEEN REPORTED FOR THIS FG LOT 1140945. APPROXIMATELY (B)(4) UNITS OF NEURAGEN PRODUCTS HAVE BEEN SHIPPED FOR SALES PURPOSES SINCE DECEMBER 2014 UNTIL DECEMBER 2016, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY(B)(4). CONCLUSION: (ROOT/CAUSE) THE REPORTED INCIDENT (EXPIRED PRODUCT IMPLANTED) COULD NOT BE ASSOCIATED TO THE MANUFACTURING / PACKAGING PROCESS PERFORMED. COMPLAINT UNIT WAS LABELED IN AN ACCURATE MANNER AND APPLICABLE PROCEDURES. THE PACKAGED PRODUCT HAD SEVERAL LABELS THAT CONTAINED THE EXPIRATION DATE THAT ARE VERY NOTICEABLE BY THE END USER, THEREFORE THE REPORTED INCIDENT COULD BE ASSOCIATED TO INAPPROPRIATE HANDLING OF THE PRODUCT (PRODUCT MISUSE) BY THE REPORTING FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS IMPLANTED ON A (B)(6) FEMALE. PATIENT WAS NOT INJURED AND NO ADVERSE EFFECTS HAS BEEN REPORTED. THE DEVICE WILL REMAIN IMPLANTED. PATIENT IS AWARE OF THE EXPIRED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10532 NEURAGEN NERVE GUIDE 6MM ID X 3CM LENGTH NEURAGEN JXI INTEGRA LIFESCIENCES CORPORATION 1140945

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other