BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 7245722 · Received February 6, 2018

    Report

    Report Number
    1226348-2018-10108
    Event Type
    Injury
    Date Received
    February 6, 2018
    Date of Event
    January 5, 2018
    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 · 0

    THE SENSOR WAS RETURNED AND EVALUATED BY THE SUPPLIER. A REVIEW OF MANUFACTURING RECORDS FOUND THE COMPONENT MET ALL MANUFACTURING AND QUALITY/TESTING SPECIFICATIONS PRIOR TO DISTRIBUTION. EVALUATION OF THE RETURNED DEVICE FOUND THE CATHETER MATERIAL AND INTERNAL WIRES WERE STRETCHED AND BROKEN, WITH THE INTERNAL WIRES EXPOSED. THE CATHETER WAS RECEIVED IN TWO SECTIONS. DUE TO THE CONDITION OF THE DEVICE AS RECEIVED, NO TESTING WAS POSSIBLE. BASED ON THE INFORMATION AVAILABLE, THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    IT WAS PREVIOUSLY REPORTED THAT THE DEVICE WOULD NOT BE RETURNED. THE PRODUCT WAS SUBSEQUENTLY RETURNED. THIS RECORD HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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. DEVICE NOT AVAILABLE

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS AFFILIATE, A MICROSENSOR PRODUCED EXTREMELY HIGH READINGS AFTER A CT SCAN. IT IS SUSPECTED THAT THE MEDICAL TEAM MAY HAVE TUGGED ON THE MICROSENSOR WHEN MOVING THE PATIENT TO THE CT SCAN, CAUSING THE HIGH READINGS. MICROSENSOR WAS REPLACED WITH ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87410 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention