BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEURAWRAP NERVE PROTECTOR 7MM ID X 4CM LENGTH

    MDR report key: 2094006 · Received April 27, 2011

    Report

    Report Number
    1121308-2011-00011
    Event Type
    Other
    Date Received
    April 27, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 27, 2011
    Manufacturer
    INTEGRA, PLAINSBORO
    Product Code
    JXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEURAWRAP THAT WAS PURCHASED BY THE HOSPITAL ON (B)(6) 2010, AND KEPT IN THEIR INVENTORY STOCK AT THE USER FACILITY, WAS IMPLANTED DURING A SURGICAL PROCEDURE AFTER ITS LABEL EXPIRATION DATE ((B)(6) 2011). THE CIRCULATING NURSE OPENED THE PRODUCT, WITHOUT NOTICING THE EXPIRATION DATE, AND PLACED IT ONTO THE STERILE FIELD FROM WHERE IT WAS THEN IMPLANTED INTO THE PATIENT. THE CIRCULATING NURSE NOTIFIED THE SURGEON WHO ELECTED NOT TO REMOVE THE PRODUCT. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEURAWRAP NERVE PROTECTOR 7MM ID X 4CM LENGTH NEURAWRAP JXI INTEGRA, PLAINSBORO 1090796

    Patients

    Seq Age Sex Outcome Treatment
    1 Other