BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEADER LUMINOMETER

    MDR report key: 6312855 · Received February 8, 2017

    Report

    Report Number
    2024800-2017-00005
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    January 12, 2017
    Report Date
    February 8, 2017
    Manufacturer
    HOLOGIC INC.
    Product Code
    JJQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER (B)(6), EXPERIENCED A REACTION WHEN WORKING WITH BLEACH WHILE CLEANING MATERIALS IN THE LAB. APPROXIMATELY AFTER 2 HOURS, THE OPERATOR HAD RED SWOLLEN EYES AND PATCHES UNDER THE EYES. SHE DID NOT TOUCH HER FACE WITH HER GLOVES, BUT DID USE THE COLLAR OF HER LAB COAT TO WIPE HER FACE. THERE WERE NO IMMEDIATE ACTIONS TAKEN, AS THE REACTION TOOK PLACE AFTER SHE HAD LEFT FOR THE DAY. THE OPERATOR HAD BEEN TESTING SINCE (B)(6) 2016 AND HAD EYE SWELLING OCCURRED ON DIFFERENT OCCASIONS. SHE DOES NOT USE HARSH CHEMICALS AT HOME AND ONLY RECENTLY SUSPECTED THE REACTION IS DUE HER WORK WITH APTIMA. THE OPERATOR DID SEEK MEDICAL ATTENTION. THE DOCTOR HAS INDICATED THAT THE FUMES COULD BE IRRITATING HER EYES, BUT PERHAPS RUBBING THE FACE WITH THE LAB COAT COULD ALSO CAUSE THE REACTION. THE OPERATOR IS CURRENTLY NOT PERFORMING APTIMA TESTING FOR THE REMAINDER OF JAN AND FEB. IF THE PROBLEM PERSISTS IN MARCH WHEN THE OPERATOR RESUMES APTIMA TESTING THEY WILL CONTACT HOLOGIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95570 LEADER LUMINOMETER IN-VITRO DIAGNOSTICS JJQ HOLOGIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention