BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 5539887 · Received March 31, 2016

    Report

    Report Number
    1226348-2016-10253
    Event Type
    Injury
    Date Received
    March 31, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    510(K) # OF SIMILAR PRODUCT CODE 826631: K914479. UDI: (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    AT THE END OF THE COMPLAINT DESCRIPTION ON COMPLAINT (B)(4): "CLINICIAN HAD PATIENT THIS WEEK WHOSE ICP WAS READING NEGATIVE DESPITE A SCAN SHOWING A HORRIBLE CONTUSION AND MIDLINE SHIFT." ON (B)(6) 2016 REPS REPLY TO THE ABOVE: "THE SECOND COMPLAINT WAS ON THE BACK OF THE COMPLAINT, THE LAST LINE OF HER EMAIL WHICH REFERENCED THE CLINICIAN HAD AN ISSUE WITH A MICROSENSOR. I HAVE CONTACTED THE TEAM ON APPROXIMATELY 6 OCCASIONS TO TRY AND ASCERTAIN ANY FURTHER DETAIL BUT I HAVEN'T RECEIVED ANY. WHAT I CAN CONFIRM IS THAT THEY DID NOT KNOW THE LOT NUMBER AND THERE IS NO PRODUCT TO BE RETURNED. ALSO I WAS INFORMED THAT THERE WAS NO ADVERSE EVENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195788 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention