BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 6365332 · Received February 28, 2017

    Report

    Report Number
    1226348-2017-10132
    Event Type
    Injury
    Date Received
    February 28, 2017
    Date of Event
    February 8, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). 510(K) # FOR SIMILAR PRODUCT CODE OF 826631: K914479. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPDATED UDI -- (B)(4). THE SENSOR WAS RETURNED FOR EVALUATION BY THE SUPPLIER. REVIEW OF QUALITY RECORDS FOUND THAT THE DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED DEVICE FOUND THE INTERNAL WIRES WERE BROKEN INSIDE THE CATHETER. THE CATHETER MATERIAL WAS SEVERELY MASHED AND STRETCHED AT THE SUTURE LOCATION. THE CATHETER MATERIAL WAS MASHED 2.6 CM AND 20 CM FROM THE TIP. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING WAS POSSIBLE. BASED ON THEIR EVALUATION, THE SUPPLIER WAS ABLE TO CONFIRM THE REPORTED ISSUE AND DETERMINED THE CAUSE OF FAILURE TO BE MISHANDLING OF THE CATHETER. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    A MICROSENSOR STOPPED PROVIDING DATA AFTER 6 DAYS; IT WAS NOT RECOGNIZED BY THE MONITOR. AFTER CHANGING THE SENSORS POSITIION, IT RESUMED PROVIDING DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148052 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention