BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 8264522 · Received January 21, 2019

    Report

    Report Number
    1226348-2019-10046
    Event Type
    Injury
    Date Received
    January 21, 2019
    Date of Event
    January 4, 2019
    Report Date
    January 4, 2019
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED WITH TWO OTHER SENSORS (MDRS 1226348-2019-10045, 1226348-2019-10047). LABELS FOR THREE LOTS WERE PROVIDED WITH THE THREE MICROSENSORS (LOTS 152001, 186733, 162540); HOWEVER, IT WAS NOT POSSIBLE TO DETERMINE WHICH LOT WAS ASSOCIATED WITH WHICH SENSOR.

    Additional Manufacturer Narrative · 0

    UDI (B)(4). THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UDI:(B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THERE WAS NO VISIBLE DAMAGE TO THE MILLAR SENSOR, CATHETER MATERIAL, OR CONNECTOR. THE DEVICE PASSED ELECTRONIC, NOISE, LINEARITY HYSTERESIS, AND SIGNAL DRIFT TESTS. BASED ON THE EVALUATION, THE COMPLAINT HAS NOT BEEN CONFIRMED. NO FURTHER INVESTIGATION OR CORRECTIVE ACTION IS ANTICIPATED. A REVIEW OF QUALITY RECORDS FOR BOTH THE FINISHED GOOD AND THE COMPONENT FOUND NO DISCREPANCIES.

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN REPORTED THAT THE DEVICE WILL BE RETURNED FOR EVALUATION. UPON RECEIPT OF THE DEVICE OR ADDITIONAL RELEVANT INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS AFFILIATE, BEFORE IMPLANTATION, A MICROSENSOR COULD NOT BE ZEROED. IT WAS DISCARDED FOR ANOTHER. A DELAY OF 2 HOURS WAS REPORTED. THE SENSOR WILL BE RETURNED FOR EVALUATION. THIS IS THE SECOND COMPLAINT OF THREE REGISTERED FOR THIS INCIDENT; THE OTHER TWO ARE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57904 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other