BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOSONIC GERMICIDAL ULTRASONIC CLEANER CONC.

    MDR report key: 419631 · Received September 30, 2002

    Report

    Report Number
    2416455-2002-00001
    Event Type
    Other
    Date Received
    September 30, 2002
    Date of Event
    September 3, 2002
    Report Date
    September 30, 2002
    Manufacturer
    CENTRAL SOLUTIONS INC.
    Product Code
    FLG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DENTAL AUXILIARY WAS INJURED WHILE REMOVING AN 80Z. BOTTLE OF BIOSONIC GERMICIDAL ULTRASONIC CLEANER CONCENTRATE, CAT. NO. UC-38, FROM THE CARTON. SOLUTION SPRAYED INTO THEIR EYE; THEY WERE IMMEDIATELY TAKEN OF THE MEDICAL CENTER JUST DOWN THE STREET FROM THE OFFICE WHERE THE INCIDENT OCCURRED. REPORTED THAT THE CARTON CONTAINING THIS BOTTLE APPEARED SIGHTLY DAMAGED AND THAT THERE WAS A SLIGHT STAIN ON THE BOTTOM OF THE CARTON VISIBLE FROM THE OUTSIDE. UPON CLOSER EXAMINATION OF THE BOTTLE, THE REPORTER NOTED THAT THERE WAS A PIN POINT HOLE IN THE CORRESPONDING CORNER; THERE IS A VERY SMALL LEAK. PT RECOUNT THE EVENT AS IT HAPPENED AND THEY REPORTED AS FOLLOWS: THE OFFICE OF DR. HAD PURCHASED A SIX PACK, AND THE ONE BOX THAT THEY PULLED FROM THIS PACK WAS CREASED AND CRUSHED A BIT, AND THE BOTTLE WAS THEREFORE JAMMED IN THE CARTON. THEY HELD THE CARTON OPEN WITH ONE HAND AND KEPT PULLING ON THE NECK OF THE BOTTLE WITH THE OTHER HAND TO REMOVE THE BOTTLE WHICH SUDDENLY DISLODGED; THE HAND WITH THE BOTTLE CAME UP IN FRONT OF THE FACE OF THE DENTAL AUXILIARY AND SOME LIQUID SPRAYED OUT OF THE BOTTLE INTO THEIR EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSONIC GERMICIDAL ULTRASONIC CLEANER CONC. ULTRASONIC CLEANING SOLUTION FLG CENTRAL SOLUTIONS INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention