BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSED-LOOP CALORIC IRRIGATOR

    MDR report key: 20708 · Received March 13, 1995

    Report

    Report Number
    20708
    Event Type
    Injury
    Date Received
    March 13, 1995
    Date of Event
    February 23, 1995
    Report Date
    March 13, 1995
    Manufacturer
    GRAMS MEDICAL PRODUCTS
    Product Code
    JYH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO BEGIN CALORIC IRRIGATION ON RIGHT EAR, COLD WATER, PT COMPLAINED OF PAIN. RPTR STOPPED TEST, THEN NOTICED BLOOD AT RIGHT EAR. EAR CONTINUED TO BLEED FOR SEVERAL HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSED-LOOP CALORIC IRRIGATOR CLOSED-LOOP CALORIC IRRIGATOR JYH GRAMS MEDICAL PRODUCTS DA200

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| O