BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-TOUCH ELITE

    MDR report key: 3839419 · Received May 15, 2014

    Report

    Report Number
    1019632-2014-00008
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    May 14, 2014
    Manufacturer
    SHIJIAZHUANG HONGRAY GROUP CO., LTD.
    Product Code
    LYZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    OUR CUSTOMER INFORMED US THAT A CLINICIAN WITH KNOWN LATEX ALLERGY DEVELOPED SEVERE ALLERGIC REACTION AFTER USING OUR MICRO-TOUCH ELITE POWDER FREE EXAMINATION GLOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289640 MICRO-TOUCH ELITE VINYL EXAMINATION GLOVES LYZ SHIJIAZHUANG HONGRAY GROUP CO., LTD. 11117692DF

    Patients

    Seq Age Sex Outcome Treatment
    1