BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWER GRIP

    MDR report key: 239166 · Received September 8, 1999

    Report

    Report Number
    2939513-1999-00002
    Event Type
    Other
    Date Received
    September 8, 1999
    Report Date
    August 25, 1999
    Manufacturer
    P.T. IRAMA DINAMIKA LATEX
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON 8/25/1999 THE INITIAL REPORTER AND INDIVIDUAL WHO EXPERIENCED THE ADVERSE REACTION, A DENTIST INDICATED THE FOLLOWING WITH SUPPLEMENTAL INFO PROVIDED: INDIVIDUAL, DENTIST, BEGAN EXPERIENCING SYMPTOMS SUCH AS ITCHING, SNEEZING, WATERY EYES AND RED HANDS, BUT CONTINUED THE USE OF POWDERED NATURAL RUBBER LATEX GLOVES FOR APPROX ONE WEEK BELIEVING THAT THE SYMPTOMS WOULD SUBSIDE ON THEIR OWN. INDIVIDUAL STATED THAT UPON BEGINNING TO EXPERIENCE DIFFICULTY BREATHING, AND SORES DEVELOPING BETWEEN HIS FINGERS ON HIS RIGHT HAND, HE WENT TO THE EMERGENCY ROOM (ER) WHERE HE WAS DIAGNOSED AS HAVING CARDIAC ASTHMA AND WAS GIVEN TREATMENT FOR APPROX TWO WEEKS FOLLOWING HIS ER VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER GRIP LATEX EXAMINATION GLOVES LYY P.T. IRAMA DINAMIKA LATEX PG-199 94027

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other