BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRICULAR BOLT ICP MONITOR KIT W/CRANIAL ACCES

    MDR report key: 4200042 · Received October 21, 2014

    Report

    Report Number
    2023988-2014-00053
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    INTEGRA NEURO SCIENCES
    Product Code
    GWM
    PMA / PMN Number
    K914735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICES INVOLVED IN THE REPORTED INCIDENT HAVE NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THERE WAS A DISCREPANCY BETWEEN THE PACKING LIST EXPIRATION OF 04/01/2015 AND THE PRODUCT BOX LABEL WHICH STATED AN EXPIRATION DATE OF 04/01/2014. THE BOX LABEL APPEARED THAT THE PRODUCT WAS EXPIRED. THERE WAS NO PT CONTACT AND NO PT INJURY. NO PT WAS PREPPED FOR SURGERY. NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669838 VENTRICULAR BOLT ICP MONITOR KIT W/CRANIAL ACCES NA GWM INTEGRA NEURO SCIENCES 210759

    Patients

    Seq Age Sex Outcome Treatment
    1