BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURAGEN 3MM X 3CM GUIDE

    MDR report key: 7980938 · Received October 18, 2018

    Report

    Report Number
    1121308-2018-00093
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    September 21, 2018
    Report Date
    September 21, 2018
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    JXI
    PMA / PMN Number
    K011168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION, NONETHELESS, THE COMPLAINT IS A CUSTOMER ERROR. THE DOCUMENTATION REVIEW OF LOT 1162798 DID NOT REVEAL ANY ANOMALIES THAT COULD CAUSE THE REPORTED CONDITION. PRODUCT WAS LABELED WITH THE CORRECT EXPIRATION DATE. DOCUMENTATION AND PRODUCT RETAIN EVALUATION SHOWS THAT THE PRODUCT WAS LABELED WITH THE CORRECT EXPIRY DATE. THUS, THIS EVENT WAS RELATED TO A CUSTOMER OVERSIGHT OF THE EXPIRATION DATE AT THE TIME OF PRODUCT USE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EXPIRED NERVE TUBE WAS USED. THE SALES REP WAS NOT PRESENT FOR THE CASE; SURGEON AND HOSPITAL FAILED TO CHECK EXPIRATION BEFORE OPENING. NO PATIENT INJURY REPORTED AND NO REVISION IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818667 NEURAGEN 3MM X 3CM GUIDE N/A JXI INTEGRA LIFESCIENCES CORPORATION 1162798

    Patients

    Seq Age Sex Outcome Treatment
    1