BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO VENTRICULAR BOLT ICP MONITORING KIT

    MDR report key: 2380303 · Received November 10, 2011

    Report

    Report Number
    2023988-2011-00045
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Report Date
    November 10, 2011
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INDIVIDUAL CARTON PACK AND THE OUTER PACKING WERE RECEIVED SEALED. HOWEVER, THE PART OF THE INDIVIDUAL PLASTIC PACKAGE WAS UNSEALED. THE PRODUCT PROBLEM WAS FOUND DURING INSPECTION AT THE DELIVERY SITE. ONE MICRO VENTRICULAR BOLT ICP MONITORING KIT (1104HM) WAS AFFECTED. THERE WAS NO PT CONTACT. THE PRODUCT WAS NOT USED BY THE HOSPITAL. CROSS REFERENCED TO MANUFACTURER REPORT NUMBERS: 2023988-2011-00037 AND 2023988-2011-00038 (SAME CUSTOMER, SAME PROBLEM, DIFFERENT PRODUCTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO VENTRICULAR BOLT ICP MONITORING KIT NA GWM INTEGRA NEUROSCIENCES CA/USA 305000210775

    Patients

    Seq Age Sex Outcome Treatment
    1