BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1643617 · Received March 16, 2010

    Report

    Report Number
    1643617
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    December 8, 2009
    Report Date
    March 3, 2010
    Manufacturer
    REMEL
    Product Code
    OPU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT SWABBED PER GUIDELINES FOR RULE OUT. SWAB INSERTED INTO RIGHT NARE BY RN. UPON REMOVAL OF SWAB, COTTON COVERED WIRE CURETTE WAS NO LONGER ATTACHED. (B) (4) NOTIFIED AND ATTEMPTS TO REMOVE BY SUCTION WERE UNSUCCESSFUL. OCEAN NASAL SPRAY ORDERED, BUT THUS FAR CURETTE IS STILL LODGED IN NARES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MICROTEST MULTI-MICROMEDIA (H1N1 SWAB) OPU REMEL * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR