BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EARIGATOR

    MDR report key: 311060 · Received January 4, 2001

    Report

    Report Number
    MW4002920
    Event Type
    Malfunction
    Date Received
    January 4, 2001
    Report Date
    January 4, 2001
    Manufacturer
    SURYA TECHNOLOGIES INTERNATIONAL
    Product Code
    JYH
    Report Source
    Voluntary report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    RECEIVED A EARIGATOR (EAR IRRIGATOR) FROM SURYA TECHNOLOGIES INTERNATIONAL, MODEL: EAR-GRB, 120 VOLTS AND FOR $3,495.00. OUTPATIENT CLINIC REQUESTED THIS DEVICE. THE OPERATOR MANUAL SPEC STATES THAT THE WATER PRESSURE RANGE IS 10 TO 12 PSI. WHEN TESTED AT THE HAND PIECE NOZZLE TIP, IT IS A LITTLE OVER 23 PSI UNDER A NO FLOW CONDITION AND VERY LITTLE PRESSURE UNDER A FLOW CONDITION. THE CO REP TOLD THE RPTR THAT THE MFR SAID THAT THE PRESSURE WOULD BE "ALL RIGHT". SURYA TECHNOLOGIES INTERNATIONAL FAXED RPTR A COPY OF A LETTER FROM THE FDA, OFFICE OF DEVICE EVALUATION, RE: K992840, TRADE NAME: EARIGATOR EAR CLEANSING INSTRUMENT, DATED 8/31/99. THIS LETTER STATES THAT THE OFFICE REVIEWED SURYA PREMARKET NOTIFICATION SUBMISSION AND HAVE FOUND THIS DEVICE TO BE EXEMPT FORM THE PREMARKET NOTIFICATION REQUIREMENTS OF THE FEDERAL FOOD, DRUG AND COSMETIC ACT. THIS LETTER STATES THAT "YOU (SURYA) MAY IMMEDIATELY BEGIN MARKETING THIS DEVICE AS DESCRIBED IN YOUR (SURYA) PREMARKET NOTIFICATION". RPTR IS REQUESTING TECHNICAL ADVICE OR THE FDA PROTOCOL FOR VERIFING THE SAFETY AND PERFORMANCE OF THIS DEVICE BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426 EARIGATOR EAR IRRIGATOR 120 VOLTS JYH SURYA TECHNOLOGIES INTERNATIONAL EAR-GRB NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO