BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL SHIELD GOLD GLOVES

    MDR report key: 1843532 · Received September 20, 2010

    Report

    Report Number
    MW5017548
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 20, 2010
    Manufacturer
    SGMP CO. LTD
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) PATIENT OF DR (B)(6)- HAD AN ADVERSE REACTION TO A DENTAL PROCEDURE. ONE OF THE ITEMS USED IN THE PROCEDURE WERE VITAL SHIELD GOLD GLOVES PROVIDED BY MY COMPANY. THESE ARE POWERED LATEX GLOVES. THE LOT NUMBER IN QUESTION FOR THE SIZE 9.0 GLOVES IS 9197182-6923. NO OTHER REPORTS OF ADVERSE REACTION HAVE BEEN REPORTED WITH EITHER THIS LOT NUMBER OR ANY OTHER LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL SHIELD GOLD GLOVES NON-STERILE MEDICAL EXAMINATION GLOVES SIZE 9 POWERED LYY SGMP CO. LTD * 9197182-6923

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| O