BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHERLOCK 3CG SENSOR (RADEL)

    MDR report key: 12060447 · Received June 24, 2021

    Report

    Report Number
    3006260740-2021-02441
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 4, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741163043
    PMA / PMN Number
    K061240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. A HISTORY REVIEW OF SERIAL NUMBER (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS SERIAL NUMBER.

    Description of Event or Problem · 1

    PER BIOMED: DOES NOT PICK UP AND SPIKE MY P WAVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955453 SHERLOCK 3CG SENSOR (RADEL) CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 9770352 00801741163043

    Patients

    Seq Age Sex Outcome Treatment
    1 Other