BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGNIFY STREP A TEST

    MDR report key: 147003 · Received January 13, 1998

    Report

    Report Number
    2030538-1998-00001
    Event Type
    Other
    Date Received
    January 13, 1998
    Date of Event
    December 5, 1997
    Report Date
    January 13, 1998
    Manufacturer
    WYNTEK DIAGNOSTICS, INC.
    Product Code
    GTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 12/05/1997, THE PEDIATRIC NURSING SUPERVISOR AT THE ACCOUNT SPLASHED HER EYE WITH REAGENT, WHILE TEACHING A HLTH TECHNICIAN HOW TO RUN THE SIGNIFY STREP A TEST. THE HLTH TECHNICIAN WAS WRINGING THE SWAB AGAINST THE SIDE OF THE TUBE AFTER THE EXTRACTION STEPS WERE PERFORMED WHEN THE SWAB CAME OUT OF THE TUBE AND SPLASHED THE SUPERVISOR IN THE EYE. BOTH REAGENT 1 AND 2 WERE IN THE TUBE ALONG WITH THE PT SWAB, FROM A HLTH TECH. AFTER THE INCIDENT, THE SUPERVISOR IMMEDIATELY FLUSHED HER EYE AT THE WASH STATION. A PHYSICIAN EXAMINED HER EYE AND STATED THERE MAY BE AN ABRASION ON THE SURFACE, POSSIBLY CAUSED BY BURNING OF THE TISSUE FROM THE CHEMICALS. THE PHYSICIAN TREATED THE SUPERVISOR WITH AN OPHTHALMIC TOPICAL ANTIBIOTIC SOLUTION. ON 12/16/1997, FURTHER INFO WAS REC'D FROM THE ACCOUNT. THE DR CONFIRMED A CORNEAL ABRASION FROM A CHEMICAL BURN. THE SUPERVISOR WAS TAKING 3 DROPS OF BLEP 3 TIMES PER DAY AND WAS WEARING AN EYE PATCH. SHE ALSO STATED THAT HER EYE WAS STILL IRRITATED BUT HEALING. NO FURTHER PT INFO HAS BEEN REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNIFY STREP A TEST QUALITATIVE TEST TO DETEST GROUP A STREP GTZ WYNTEK DIAGNOSTICS, INC. NA 33354M200

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other