BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEST M4 FEMALE/MALE KIT

    MDR report key: 840322 · Received February 27, 2007

    Report

    Report Number
    1924669-2007-00001
    Event Type
    Malfunction
    Date Received
    February 27, 2007
    Date of Event
    February 2, 2007
    Report Date
    February 27, 2007
    Manufacturer
    REMEL, INC.
    Product Code
    LIO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE COMPONENT IS SUPPLIED COMPLETE BY A SUB-CONTRACTOR. THE SUB-CONTRACTOR HAS BEEN NOTIFIED OF THIS INCIDENT. NO OTHER REPORTS HAVE BEEN RECEIVED FOR THIS COMPONENT LOT AND IS CONSIDERED TO BE AN ISOLATED OCCURRENCE. THIS COMPONENT FROM THIS SUPPLIER HAS BEEN USED FOR MORE THAN 2 YEARS WITHOUT ANY REPORTED INCIDENTS.

    Description of Event or Problem · 1

    STAINLESS STEEL SHAFT SWAB WAS USED TO COLLECT NASAL SAMPLE FROM PATIENT. THE TIP OF THE SWAB WAS RETAINED IN THE PATIENT'S NOSE. PATIENT WAS REFERRED TO AN EAR, NOSE, AND THROAT PHYSICIAN TO HAVE THE TIP REMOVED. NO FOLLOW UP VISIT OR FURTHER TREATMENT IS BEING PURSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTEST M4 FEMALE/MALE KIT SINGLE USE DISPOSABLE SAMPLE COLLECTION LIO REMEL, INC. * 502224

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention