BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1004488 · Received February 22, 2008

    Report

    Report Number
    9680651-2008-00001
    Event Type
    Other
    Date Received
    February 22, 2008
    Manufacturer
    SEAL POLYMER INDUSTRIES BHD.
    Product Code
    LYY
    PMA / PMN Number
    K991849
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A SMALL PERCENTAGE OF THE POPULATION MAY EXPERIENCE ALLERGIC REACTION TO (I) INHERENT PLANT PROTEIN IN THE GLOVES. (II) TO ANTIOXIDANTS AND ACCELERATORS, ADDED TO THE GLOVES DURING THE MFG PROCESS. THE STEPS UNDERTAKEN TO REDUCE PROTEIN AND CHEMICAL RESIDUE LEVEL IN GLOVE IN ORDER TO MINIMIZE SKIN IRRITATION ARE AS FOLLOWS: INCORPORATION OF PRE AND POST LEACHING TANKS IN THE PRODUCTION LINE. THE TEMP OF THESE TANKS ARE 55-95 DEGREE CELSIUS. CHLORINATION PROCESS ON-LINE AND ITS SUBSEQUENT DILUTION AND RINSING TANKS FURTHER DRIVE DOWN THE PROTEIN LEVELS WITHIN THE GLOVE. THE GLOVE FURTHER UNDERGOES OFF-LINE CHLORINATION, FOLLOWED BY 2 RINSES IN ORDER TO OBTAIN THE FINAL PRODUCT. EACH OF THE ABOVE MENTIONED STAGES UNDERTAKEN SERVE TO REDUCE THE PROTEIN AND RESIDUE CHEMICAL LEVELS SIGNIFICANTLY WITHIN THE GLOVE. EVAL OF RETURNED SAMPLES - THE PROTEIN LEVEL WAS NEGLIGIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * LYY SEAL POLYMER INDUSTRIES BHD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1