BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOPOLAR NEEDLE

    MDR report key: 2576145 · Received May 7, 2012

    Report

    Report Number
    3008289288-2012-00002
    Event Type
    Other
    Date Received
    May 7, 2012
    Date of Event
    April 12, 2012
    Report Date
    May 7, 2012
    Manufacturer
    CAREFUSION NEUROCARE
    Product Code
    IKT
    PMA / PMN Number
    K973442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT DESIGN, BIOCOMPATIBILITY TESTING WAS CONDUCTED AND PASSED SENSITIVITY TESTS PER THE ISO 10993 STANDARD. THIS PRODUCT HAS BEEN MANUFACTURED IN THE SAME MANNER FOR THE PAST THREE YEARS AND NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN RECEIVED. THERE HAVE BEEN NO MATERIAL, PROCESS OR CHEMICAL CHANGES WHEN MFG THE MONOPOLAR NEEDLES. THE DHR FOR THIS LOT WAS REVIEWED AND ALL RESULTS ARE ACCEPTABLE. ALL COMPONENTS FOR THE MONOPOLAR NEEDLES ARE LATEX FREE. THE DOCTOR ALSO NOTED THAT THE PT WAS HYPERSENSITIVE TO THE LATEX.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT PT EXPERIENCED REACTIONS AFTER USING THE MONOPOLAR NEEDLES. PT IS ALLERGIC TO LATEX. ACCORDING TO THE DOCTOR, SHE WAS USING A RED NEEDLE HUB NEEDLE ON THE UPPER ARM AND AN ORANGE HUB NEEDLE WAS USED ON THE LOWER EXTREMITIES. PT HAD A REACTION OF ITCHINESS, RAISED BUMP AND REDNESS NEAR THE PUNCTURE SITE. THE PT DID NOT RECEIVE TREATMENT FOR THE INJURIES AND NO F/U TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR NEEDLE MONOPOLAR NEEDLE IKT CAREFUSION NEUROCARE 902-DMF37-S G1110P03

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other