BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 6861655 · Received September 13, 2017

    Report

    Report Number
    1226348-2017-10671
    Event Type
    Injury
    Date Received
    September 13, 2017
    Date of Event
    July 10, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 510 (K) # OF SIMILAR PRODUCT CODE OF 826631: K914479. IT IS NOT CLEAR AT THIS POINT IF THE DEVICE AND/OR LOT INFORMATION IS AVAILABLE. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF THE DEVICE IS RETURNED THE COMPLAINT WILL BE INVESTIGATED AND A FOLLOW UP REPORT WILL BE FILED. IF LOT INFORMATION DOES BECOMES AVAILABLE AND IF THE RECORD REVIEW INDICATES THAT THERE WAS A NON-CONFORMITY A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AS REPORTED, AFTER SURGERY, A MICROSENSOR BEGAN READING CONSISTENTLY NEGATIVE NUMBERS. NO OTHER INFORMATION IS AVAILABLE. NO CONTACT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642249 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention