BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN ELASTEX NYTRIL GLOVE PF LF

    MDR report key: 1785817 · Received July 29, 2010

    Report

    Report Number
    3007143314-2010-00001
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 30, 2010
    Manufacturer
    GX CORPORATION SDN BHD
    Product Code
    LZA
    PMA / PMN Number
    K081315
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TYPE OF EVALUATION PERFORMED - OTHER: TESTED BEFORE ACCORDING TO ISO (B)(4) (BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND DELAYED-TYPE HYPERSENSITIVITY) FOR FDA 510 (K) SUBMISSION. CONCLUSION: THERE WAS NO SENSITISATION INDUCED BY THE TEST MATERIAL ON ALBINO GUINEA PIGS; AND NONE IRRITANT WHEN TESTED ON RABBITS. CONCLUSION: USING THE EVALUATION METHOD MENTIONED ABOVE, THERE WAS NO OBSERVABLE REACTION ON THE HAND OF ALL SUBJECTS TESTED WHEN HELD IN CONTACT WITH THE TEST MATERIAL FOR THREE (3) HOURS.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT (HYGIENIST), WHO HAS A HISTORY OF HAVING VERY SENSITIVE HANDS, WORE THESE GLOVES WHICH ALLEGEDLY DRIED OUT HER HANDS AND MADE THEM BLEED. THE PATIENT ALSO DEVELOPED AN INFECTION ON ONE THUMB WHICH LOOKED LIKE A VERY BAD BURN THAT WAS BLEEDING. PATIENT WENT TO A DERMATOLOGIST WHO PRESCRIBED STEROIDS, ANTIBIOTICS AND A CREAM. HER HANDS ARE FINE NOW AFTER USING THE PRESCRIBED MEDICATION. SHE WAS THE ONLY PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN ELASTEX NYTRIL GLOVE PF LF ELASTEX NYTRIL GLOVE PF LF LZA GX CORPORATION SDN BHD G25R09S001

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other