BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN INC.

    MDR report key: 8710399 · Received June 14, 2019

    Report

    Report Number
    3005632797-2019-00001
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    April 30, 2019
    Report Date
    June 12, 2019
    Manufacturer
    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.
    Product Code
    LYY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAD REVIEWED OUR RECORDS AND CONDUCTED EXTRACTABLE PROTEIN TEST ON RETENTION SAMPLES AND GLOVES RETURNED FROM CUSTOMER. WE CONCLUDE THAT THERE WAS NO ABNORMALITY ON THE COMPOUNDED LATEX PH AND TOTAL SOLID COMPOUND (TSC%), PRODUCTION PROCESS PARAMETERS, QUALITY OF THE GLOVES AND EXTRACTABLE PROTEIN TEST RESULTS. THERE WAS NO CHANGE OF PROCESS PARAMETERS, AND ALL PARAMETERS WERE WITHIN THE SPECIFICATION, DURING THE PRODUCTION OF THIS LOT SIZE. THE RETENTION GLOVES TESTED FOR EXTRACTABLE PROTEIN TEST, PH TEST AND DONNING TEST DID NOT EXHIBIT ANY IRREGULARITY. THE GLOVES RETURNED FROM CUSTOMER WHICH WERE SUBMITTED FOR EXTRACTABLE PROTEIN TEST AND DONNING TEST ALSO DID NOT EXHIBIT ANY IRREGULARITY. WE BELIEVE THE COMPLAINT BY THE MEDICAL ASSISTANT IS AN ISOLATED CASE DUE TO WRONG GLOVE BEING USED AS THE USER DEVELOPED ALLERGIC REACTION OVER A PERIOD OF TIME OF WEARING NATURAL RUBBER GLOVES AT WORK PLACE.

    Description of Event or Problem · 1

    A FEMALE DENTAL ASSISTANT WAS WEARING LATEX GLOVES WHEN SHE STARTED HAVING DIFFICULTY BREATHING AND HER THROAT STARTED TO FEEL AS IF IT WAS SWELLING. THE ASSISTANT STATED SHE BELIEVES SHE HAS AN ALLERGY TO RUBBER, ELASTIC AND LATEX FROM YEARS OF WEARING THESE MATERIALS. THE ASSISTANT DID NOT SEEK ANY MEDICAL ATTENTION AND WAS NOT PRESCRIBED ANY MEDICATION, NOR DID SHE TAKE ANY OTC MEDICATIONS TO TREAT THE REACTION. THE SWELLING WAS REPORTED TO SUBSIDE ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495580 HENRY SCHEIN INC. LATEX PATIENT EXAMINATION GLOVE LYY KOSSAN LATEX INDUSTRIES (M) SDN. BHD. K10048407

    Patients

    Seq Age Sex Outcome Treatment
    1 Other