BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUPREP GEL

    MDR report key: 823855 · Received February 28, 2007

    Report

    Report Number
    1718791-2007-00001
    Event Type
    Injury
    Date Received
    February 28, 2007
    Date of Event
    January 1, 2002
    Report Date
    February 27, 2007
    Manufacturer
    D. O. WEAVER AND COMPANY
    Product Code
    GYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    I HEARD ABOUT THIS EVENT THROUGH A PRIVATE CONVERSATION AT A PROFESSIONAL MEETING OF EEG TECHNICIANS. THIS CONVERSATION OCCURRED ON FEBRUARY 21, 2007. THE FACILITY HAS NOT YET DISCLOSED MUCH INFO TO ME, BUT I AM FAIRLY CONVINCED THAT THE CIRCUMSTANCES THAT I AM DESCRIBING ARE ACCURATE. A CALL TO THE NEURODIAGNOSTIC LAB DIRECTOR, ON FEBRUARY 23, 2007 CONFIRMS THAT AN EVENT OF THIS APPROXIMATE NATURE DID, IN FACT, OCCUR. SHE COULD NOT DISCLOSE MUCH INFO, PRESUMABLY FOR LEGAL REASONS. ON FEBRUARY 26TH, 2007, I CALLED THE LOSS MANAGEMENT DEPARTMENT AND SPOKE TO ANOTHER PERSON. SHE KNEW SOMETHING OF THE INCIDENT AND OUR PRODUCTS, NUPREP AND TEN20 WERE FAMILIAR TO HER BUT SHE WOULD NOT DISCUSS THE EVENT AND REFERRED ME TO THEIR LEGAL DEPARTMENT. I CALLED THE LEGAL DEPARTMENT ON FEB 26, 2007 AND WAS PUT IN HER VOICE MAIL, WHERE I LEFT A MESSAGE TO CALL ME. I MADE THREE CALLS AND EACH TIME LEFT MESSAGES IN VOICE MAIL ON FEB 26 AND 27. I HAVE NOT REC'D A CALL YET. PAST INSTRUCTIONS, INCLUDED WITH NUPREP GEL IN 2002 WERE STATED AS FOLLOWS: "AVOID EYE CONTACT: NUPREP GEL CONTAINS ALUMINUM OXIDE PARTICLES THAT ARE INSOLUBLE. IF NUPREP GEL IS INTRODUCED IN THE EYE, RINSE WITH APPROPRIATE 0.9% SALINE OR EYEWASH SOLUTION. AVOID RUBBING THE EYES." SINCE THEN WE HAVE MODIFIED THE INSTRUCTION TO READ: "AVOID EYE CONTACT. IF INTRODUCED IN THE EYE, RINSE WITH WATER FOR 10 TO 15 MINUTES. AVOID RUBBING THE EYES." IN 2002, EACH TUBE HAD AN INTERNATIONAL ATTENTION TRIANGLE PRINTED ON IT WITH THE WORDS ATTENTION: FOR DETAILS SEE INSTRUCTION SHEET. ALSO, IN 2002, ALL INGREDIENTS WERE LISTED ON THE JAR AND ON THE INSTRUCTION SHEET IN DESCENDING ORDER OF CONTENTS. WE ARE INTERNALLY DISCUSSING THIS ALLEGED INCIDENT AT A HIGH LEVEL IN OUR ORGANIZATION AND WILL INITIATE A CORRECTIVE AND PREVENTIVE ACTION REPORT (CPAR) TO COMPREHENSIVELY CONSIDER AND IMPLEMENT PREVENTIVE ACTION(S) WHERE APPROPRIATE.

    Description of Event or Problem · 1

    PT HAD EEG EXAM. THIS EXAM IS REPORTED TO HAVE BEEN CONDUCTED IN 2002. ELECTRODE CONDUCTIVE AND ABRASIVE MATERIAL MAY HAVE BEEN INTRODUCED INTO THE EYE ACCIDENTALLY DURING TEST. NO FLUSHING OF EYE. IT IS REPORTED THAT THE PT HAS LOST SOME OR ALL OF SIGHT IN THE SAME EYE IN WHICH THE PRODUCT MAY HAVE BEEN INTRODUCED IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUPREP GEL SKIN PREP GEL GYB D. O. WEAVER AND COMPANY 10-30 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability