BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERRY STYLE 42

    MDR report key: 3674456 · Received February 4, 2014

    Report

    Report Number
    1019632-2014-00004
    Event Type
    Injury
    Date Received
    February 4, 2014
    Report Date
    February 4, 2014
    Manufacturer
    ANSELL SHAH ALAM SDN. BHD
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CATALOG NUMBER: 5711103. ADDITIONAL LOT NUMBERS: 1205106121, 1204013821.

    Description of Event or Problem · 1

    AN MDR IS BEING FILED AFTER OUR COMPANY LEARNED THAT A DOCTOR DEVELOPED RUNNY NOSE, AND HER STAFF DEVELOPED ITCHINESS AND RASH ON HANDS AFTER USING OUR PERRY STYLE 42 SURGICAL GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71986 PERRY STYLE 42 LATEX POWDERED SURGICAL GLOVES KGO ANSELL SHAH ALAM SDN. BHD 1212044421

    Patients

    Seq Age Sex Outcome Treatment
    1 Other