BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KALLSTEAD HEP-2 AND ANCA

    MDR report key: 8075780 · Received November 15, 2018

    Report

    Report Number
    1000135116-2018-00001
    Event Type
    Injury
    Date Received
    November 15, 2018
    Date of Event
    November 7, 2018
    Report Date
    November 15, 2018
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    DBM
    UDI-DI
    00847817016103
    PMA / PMN Number
    K982898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER IS A NURSE. WHEN OPENING THE FRIDGE, ANCA OR HEP-2 SLIDES FELL (ABOUT 4 TO 5 SLIDES). ATTEMPTING TO PICK UP THE BROKEN SLIDES THE CUSTOMER CUT HERSELF ALTHOUGH SHE WAS WEARING PROTECTIVE GLOVES. THE CUSTOMER WASHED HER HANDS THOROUGHLY WITH SOAP AND LEFT HER FINGER IN THE ALCOHOL FOR ABOUT 40 MINUTES. A SEROLOGY CHECK WILL BE DONE IN 7 WEEKS. THE CUSTOMER WENT TO SEE A DOCTOR. THE DOCTOR HAS ASSURED THE CUSTOMER THAT THERE IS NO HIV RISK , BECAUSE THE SLIDES WERE OLD AND DATED AS OF 2012. CUSTOMER WAS INJURED ON (B)(6) 2018. (B)(6) CUSTOMER REP (B)(6) WILL CONTACT CUSTOMER FOR FOLLOWUP INFORMATION IN 7 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912731 KALLSTEAD HEP-2 AND ANCA ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL DBM BIO-RAD LABORATORIES, INC. N/A N/A 00847817016103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other