BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE ETS NITRILE PATIENT EXAM GLOVES

    MDR report key: 2104106 · Received April 21, 2011

    Report

    Report Number
    1451040-2011-00001
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 21, 2011
    Manufacturer
    PERUSAHAAN GETAH ASAS SDN. BHD.
    Product Code
    LZA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CYPRESS INITIALLY RECEIVED A REPORT OF THREE NURSES IN THE FACILITY'S SICU DEVELOPING A RASH AFTER INTRODUCTION OF THE MEDICHOICE ETS NITRILE GLOVES. THEN, CYPRESS LEARNED OF THREE MORE NURSES REPORTEDLY FROM A DIFFERENT UNIT EXPERIENCING THE SAME ISSUE. RECENTLY, THE FACILITY REPORTED TO US THAT THEY ARE AMENDING THEIR INITIAL MEDWATCH REPORT BECAUSE THEY HAD DETERMINED THAT ALL SIX NURSES ARE FROM THE SAME UNIT. CYPRESS DOES NOT HAVE A COPY OF THE AMENDMENT. OTHER CATALOG NUMBERS 1773GLV2003 AND 1773GLV2004. OTHER LOT NUMBERS MOK01-04 AND MOJ11-05.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICHOICE ETS NITRILE PATIENT EXAM GLOVES NITRILE EXAM GLOVES LZA PERUSAHAAN GETAH ASAS SDN. BHD. MOJ07-07

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other