BEUDAMED
    FDA Adverse Event Other Summary report: N

    EAR IRRIGATION SYRINGE

    MDR report key: 449574 · Received March 19, 2003

    Report

    Report Number
    MW1027933
    Event Type
    Other
    Date Received
    March 19, 2003
    Date of Event
    February 5, 2003
    Report Date
    March 7, 2003
    Manufacturer
    MILTEX INSTRUMENT CO. INC.
    Product Code
    KCP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    MEDICAL ASSISTANT CLEANING PT'S LEFT EAR AND THE EAR IRRIGATION SYRINGE CAME APART AND SCRATCHED PT'S EXTERNAL EAR CANAL. ABRASION MINOR WITH SLIGHT BLOOD <1CC. FOLLOW UP: THE MEDICAL ASSISTANT THOUGHT SHE HAD ASSEMBLED THE SYRINGE CORRECTLY, BUT APPARENTLY MUST NOT HAVE DONE SO. STAFF CHECKED THE SYRINGE OUT THOROUGHLY. THERE HAVE BEEN NO FURTHER INCIDENTS AND STAFF IS DOING A DOUBLE-CHECK TO MAKE SURE IT IS SECURED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAR IRRIGATION SYRINGE SYRINGE, IRRIGATION KCP MILTEX INSTRUMENT CO. INC. 19-385 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other