BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURAGEN NERVE GUIDE 6M ID X 3CM LENGTH

    MDR report key: 1853208 · Received September 28, 2010

    Report

    Report Number
    1121308-2010-00022
    Event Type
    Other
    Date Received
    September 28, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 28, 2010
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    JXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION. ACCORDING TO THE ASSOCIATION OF PERIOPERATIVE REGISTERED NURSES (AORN). RECOMMENDED PRACTICE FOR MAINTAINING A STERILE FIELD, EFFECTIVE 01/01/2006, RECOMMENDATION III, "ITEMS USED WITHIN THE STERILE FIELD SHOULD BE STERILE." PARAGRAPH 1. "IF AN EXPIRATION DATE IS PROVIDED, THE DATE SHOULD BE CHECKED BEFORE THE PACKAGE IS OPENED AND THE CONTENTS ARE DELIVERED TO THE STERILE FIELD. OUTDATED ITEMS SHOULD NOT BE USED."

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PRODUCT WAS IMPLANTED AT A DATE LATER THAT THE PRODUCT LABELED EXPIRY DATE. THE PRODUCT WAS USED DURING A PERONEAL NERVE REPAIR PROCEDURE. THERE HAS BEEN NO ADVERSE OUTCOME TO DATE. THE DEVICE IS AN ABSORBABLE COLLAGEN TUBE DESIGNED TO BE AN INTERFACE BETWEEN THE NERVE AND SURROUNDING TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURAGEN NERVE GUIDE 6M ID X 3CM LENGTH NEURAGEN JXI INTEGRA LIFESCIENCES CORP. 1083012

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other