BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMMEX NON LATEX SENSITIVE SURGICAL GLOVE

    MDR report key: 6051897 · Received October 24, 2016

    Report

    Report Number
    1019632-2016-00011
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    October 18, 2016
    Report Date
    November 15, 2017
    Manufacturer
    ANSELL LANKA (PVT) LTD
    Product Code
    KGO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    JUNE 27, 2017: ANSELL LANKA (PVT.), LTD. ((B)(4)) HAS INTRODUCED THREE CORRECTIVE AND PREVENTATIVE ACTIONS. AREA SEGREGATION OF LATEX AND SYNTHETIC PRODUCTS. SEPARATE LOCATIONS ARE ALLOCATED TO STORE LEFT OVER INNER PACK BINS; SEGREGATED AREAS FOR NATURAL RUBBER LATEX AND SYNTHETIC PRODUCTS. INTRODUCTION OF VISUAL MANAGEMENT COMPONENT OF INTO LINE CLEARANCE PROCEDURE. SEE ITEM 3. NEW - INTRODUCTION OF A LINE CLEARANCE PROCEDURE THAT WILL DOCUMENT THE AMOUNT OF PRODUCT REMAINING AFTER A PACKAGING OPERATION AND THE CLEARANCE OF THE LINE BEFORE A NEW PACKAGING OPERATION (OF A NEW PRODUCT) CAN COMMENCE SO THAT STOCK FROM PREVIOUS SHIFT IS NOT CO-MINGLED. OCTOBER 27, 2017: FDA COMMUNICATED THAT RECALL IS COMPLETED AND CLOSED

    Description of Event or Problem · 0

    (B)(6) INDICATED THEY HAVE SEVERAL PACKAGES OF THE GAMMEX NON LATEX SENSITIVE SURGICAL GLOVE (SIZE 8.5) BUT THE GLOVE IS A ENCORE LATEX 8.5 IN THE PACKAGE. THE LOT# IS 1607018105 AND ACCORDING TO COMMENTS, THAT HAVE FOUND 12 PAIR OF GLOVES IN WHICH THE LABEL STATES NON LATEX AND THE PRODUCT CONTAINED IS A LATEX SURGI CAL GLOVE. AS THERE IS A POSSIBILITY THAT A LATEX SENSITIVE USER WOULD ATTEMPT TO USE THE THIS GLOVE FOR ITS NON LATEX PROPERTY. ANSELL IS MAKING A SUBMISSION OF A MEDICAL DEVICE REPORT FOR THE POTENTIAL HAZARD. 11/15/2017 AFTER A COMMUNICATION OF A PRODUCT RECALL OF THE AFFECTED LOT, A CORRECTIVE AND PREVENTATIVE ACTION, FDA PROVIDED CORRESPONDENCE THAT THIS RECALL IS CLOSED AS OF 10/27/2015

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016, ANSELL HAS DETERMINED THAT 4 CASES (800 PAIR) OF SURGICAL GLOVES FROM THE 15 CASE (3000 PAIR) LOT OF 1607018105 CONTAINED AN UNKNOWN NUMBER OF PACKED ENCORE TEXTURED LATEX SURGICAL CONDOMS. THE GAMMEX NON LATEX SURGICAL GLOVE IS MADE OF NEOPRENE, A SUITABLE ALTERNATE GLOVE FOR USERS WHO MAY HAVE A NATURAL RUBBER LATEX ALLERGY. THE PACKAGING OF A NATURAL RUBBER LATEX GLOVE THEREFORE POSES A RISK TO SENSITIZED USERS. ANSELL IS INITIATING A RECALL OF THIS LOT OF PRODUCT VIA COMMUNICATION TO CUSTOMERS WHO HAVE RECEIVED THIS LOT OF PRODUCT.

    Description of Event or Problem · 1

    (B)(6) HOSPITAL IN (B)(6) INDICATED THEY HAVE SEVERAL PACKAGES OF THE GAMMEX NON LATEX SENSITIVE SURGICAL GLOVE (SIZE 8.5) BUT THE GLOVE IS A ENCORE LATEX 8.5 IN THE PACKAGE. THE LOT# IS 1607018105 AND ACCORDING TO COMMENTS, THEY HAVE FOUND 12 PAIR OF GLOVES IN WHICH THE LABEL STATES NON LATEX AND THE PRODUCT CONTAINED IS A LATEX SURGICAL GLOVE. AS THERE IS A POSSIBILITY THAT A LATEX SENSITIVE USER WOULD ATTEMPT TO USE THIS GLOVE FOR ITS NON LATEX PROPERTY, ANSELL IS MAKING A SUBMISSION OF A MEDICAL DEVICE REPORT FOR THE POTENTIAL HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703571 GAMMEX NON LATEX SENSITIVE SURGICAL GLOVE SURGEON'S GLOVE, PRODUCT CODE: KGO KGO ANSELL LANKA (PVT) LTD 20277285 1607018205

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O