BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 2322107 · Received October 19, 2011

    Report

    Report Number
    2023988-2011-00037
    Event Type
    Malfunction
    Date Received
    October 19, 2011
    Report Date
    October 19, 2011
    Manufacturer
    INTEGRA, SAN DIEGO
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE OUTER PACKAGE AS WELL AS THE INDIVIDUAL CARTON FOR EACH OF THE OLM INTRACRANIAL PRESSURE MONITORING KIT (1104B) WERE RECEIVED CLOSED BY THE CUSTOMER. HOWEVER, THE "INNER PLASTIC PACKING" FOR EACH ITEM WAS RECEIVED UNSEALED. THERE WERE 21 UNITS OF THE 1104B AFFECTED. NO OTHER INFO WAS PROVIDED. ADDITIONAL CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLM INTRACRANIAL PRESSURE MONITORING KIT NA GWM INTEGRA, SAN DIEGO

    Patients

    Seq Age Sex Outcome Treatment
    1