BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE SURGICAL GLOVE

    MDR report key: 3535627 · Received December 9, 2013

    Report

    Report Number
    1019632-2013-00023
    Event Type
    Injury
    Date Received
    December 9, 2013
    Report Date
    December 9, 2013
    Manufacturer
    ANSELL LANKA (PVT) LIMITED
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ANSELL HEALTHCARE PRODUCTS LLS IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4).

    Description of Event or Problem · 1

    AN MDR IS BEING FILED AFTER CUSTOMER INFORMED ANSELL LLC THAT A DOCTOR FOUND BLOOD ON HIS THUMB AFTER USING ENCORE SURGICAL GLOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637811 ENCORE SURGICAL GLOVE SURGICAL GLOVES - LATX KGO ANSELL LANKA (PVT) LIMITED 1308009805

    Patients

    Seq Age Sex Outcome Treatment
    1 Other