BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHORTWAVE UV LIGHT

    MDR report key: 104959 · Received July 11, 1997

    Report

    Report Number
    104959
    Event Type
    Malfunction
    Date Received
    July 11, 1997
    Date of Event
    June 11, 1997
    Report Date
    July 11, 1997
    Manufacturer
    UVP
    Product Code
    KYC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OCCUPATIONAL INJURY 6/5/97, PT SEEN IN OCCUPATIONAL MEDICINE CLINIC WITH DIAGNOSIS OF LEFT EYE CORNEAL ABRASION & FOREIGN BODY. (PT COMPLAINT THAT GLASS BROKE ON JOB AND WENT INTO HER EYE.) 6/6: FOLLOW UP IN OCC. MED. - DIAG. RESOLVED CORNEAL ABRASION. 6/9: FOLLOW-UP IN OCC. MED. CLINIC WITH DIAGNOSIS: CORNEAL ABRASION, BILATERAL CHEMICAL CONJUNCTIVITIS - IRRIGATED WITH DACRILOSE. 6/11: FOLLOWED UP IN OCC. MED. CLINIC EXAMINED WITH UVG-54 LIGHT AND FLURACIN STRIPS. DISCHARGED WITH NEGATIVE FOREIGN BODY. 6/12: PT. IN ER WITH COMPLAINT INABILITY TO OPEN EYES. SEVERE BURNING PAIN & ITCHING. PT ALLEGES THAT LIGHT USED ON 6/11 BURNED HER EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHORTWAVE UV LIGHT SHORTWAVE UV-254MM LIGHT KYC UVP UVG-54 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Other