BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHNITRILE TECHNICALLY ADVANCED NITRILE GLOVES

    MDR report key: 1633095 · Received March 12, 2010

    Report

    Report Number
    MW5015166
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Report Date
    March 12, 2010
    Manufacturer
    TECHNIGLOVE ASIA KLANG MALAYSIA; TECHNIGLOVE INTERNATIONAL
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    STERILE GLOVES HAVE FUZZY LINT THAT ESCAPES FROM PACKAGE UPON OPENING. DATES OF USE: (B) (6) 2010 -- (B) (6) 2010. DIAGNOSIS REASON FOR USE: USED IN CLEAN ROOM TO MAKE IV PREPARATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECHNITRILE TECHNICALLY ADVANCED NITRILE GLOVES STERILE GLOVES KGO TECHNIGLOVE ASIA KLANG MALAYSIA; TECHNIGLOVE INTERNATIONAL STN200P X-SMALL 230NWT3030930XS

    Patients

    Seq Age Sex Outcome Treatment
    1 GLOVES APPEAR TO BE OK| OTHER LOT NUMBERS OF THE SAME TYPE AND SIZE OF