BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURE GRIP PF LATEX GLOVES

    MDR report key: 980463 · Received December 21, 2007

    Report

    Report Number
    2411236-2007-22514
    Event Type
    Injury
    Date Received
    December 21, 2007
    Date of Event
    November 20, 2007
    Report Date
    November 20, 2007
    Manufacturer
    PURNABINA SDN BHD
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ACCOUNT CLAIMS THEY HAD TWO ASSISTANTS WHO HAD AN ALLERGIC REACTION TO THE LATEX EXAMINATION GLOVES. (B)(6) A FEMALE HAD AN ALLERGIC REACTION AND WAS HOSPITALIZED FOR THREE DAYS. THE DOCTOR CLAIMS SHE HAD SWELLING AND AS A RESULT OF THIS SWELLING SHE ALSO HAD GASTRIC BLEEDING.

    Description of Event or Problem · 2

    ACCOUNT CLAIMS THEY HAD TWO ASSISTANTS WHO HAD AN ALLERGIC REACTION TO THE LATEX EXAMINATION GLOVES. (B)(6) A MALE HAD AN ALLERGIC REACTION MAINLY TO HIS HANDS WITH BLISTERS. HE WAS SEEN BY A DERMATOLOGIST AND GIVEN BENADRYL AND A CORTISONE CREAM. HE WAS ALSO FEELING LETHARGIC FOR SEVERAL DAYS. HE IS NOW DOING BETTER AND HAS SINCE CHANGED OVER TO VINYL GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PURE GRIP PF LATEX GLOVES POWDER FREE LATEX EXAMINATION GLOVES LYY PURNABINA SDN BHD * 0706P153

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization
    2 * Other