BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAC-1 WITH ASPIRATOR OPTION

    MDR report key: 3846043 · Received May 28, 2014

    Report

    Report Number
    MW5036430
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    September 3, 2013
    Report Date
    May 27, 2014
    Manufacturer
    LIGHTNING ENTERPRISES
    Product Code
    JYH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE HAD EXCELLENT HEARING ALL MY LIFE, BUT I NEEDED EARWAX REMOVED FROM BOTH EARS. THE AUDIOLOGIST USED A SUCTION/VACUUM DEVICE. WHEN HE PLACED THE TIP OF THE TUBE IN MY EAR AND TURNED ON THE MACHINE, I FLINCHED AND IMMEDIATELY SAID IT WAS TOO LOUD. I TRIED TO PUSH HIS HAND AWAY. HE AGREED THE MACHINE WAS LOUD BUT SAID THE PROCEDURE WOULD BE QUICK AND CAUSE NO DAMAGE. WRONG. I WAS ALMOST COMPLETELY DEAF FOR SEVERAL MONTHS AND STILL HAVE SEVERELY IMPAIRED HEARING AS CONFIRMED BY TESTS DONE IN AN ENT OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314811 VAC-1 WITH ASPIRATOR OPTION VAC-1 WITH ASPIRATOR OPTION JYH LIGHTNING ENTERPRISES

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Disability