BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOVE PROTEGRITY PF LATEX SURG 6.0

    MDR report key: 2472452 · Received February 29, 2012

    Report

    Report Number
    1423537-2012-00009
    Event Type
    Injury
    Date Received
    February 29, 2012
    Date of Event
    January 4, 2012
    Report Date
    February 29, 2012
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KGO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT AVAILABLE, ALTHOUGH A PHOTO OF THE PACKAGING WAS PROVIDED. THE LOT NUMBER ON THE PHOTO COULD NOT BE READ, AND THE CUSTOMER NO LONGER HAD THE INFORMATION. DUE TO THE UNAVAILABILITY OF THE LOT NUMBER, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. REVIEW OF THE PRODUCT DESCRIPTION SHOWN ON THE PACKAGE LABELING OF THE PROTEGRITY GLOVE CONFIRMS THAT IT IS CLEARLY STATED AS PROTEGRITY STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING, WHICH INDICATES THAT IT IS LATEX GLOVE. THE WORD "FREE" MODIFIES "POWDER" TO INDICATE THAT IT IS POWDER-FREE GLOVE. IN ADDITION TO THE PRODUCT DESCRIPTION, THERE IS A LATEX SYMBOL AND THE CAUTION ON THE PACKAGE STATING THAT "THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS INCLUDING ANAPHYLACTIC RESPONSES". FURTHERMORE, THIS PRODUCT DESCRIPTION HAS BEEN USED SINCE THE FIRST PRODUCTION OF THIS PRODUCT (B)(4), AND A REVIEW OF CUSTOMER COMPLAINT TRENDING SHOWS THAT THIS IS THE FIRST COMPLAINT RECEIVED REGARDING THIS ISSUE. CARDINAL HEALTH IS PROACTIVELY FILING THIS MEDWATCH. BASED ON ALL OF THIS INFORMATION, NO CORRECTIVE ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY UNFAVORABLE TRENDS, WHICH MIGHT REQUIRE FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    DURING A LUMBAR PUNCTURE, THIS LATEX GLOVE WAS USED ON A PATIENT WHO HAD A KNOWN LATEX ALLERGY. MEDICAL TREATMENT AND HOSPITALIZATION WERE REQUIRED (STEROIDS, BENADRYL, SUBQ EPINEPHRINE, BIPAP, HOSPITALIZED OVERNIGHT FOR OBSERVATION, AND RECEIVED ALBUTEROL BREATHING TREATMENTS). CUSTOMER BELIEVES THE GLOVE LABEL WAS A FACTOR. THE PATIENT IS NOW FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOVE PROTEGRITY PF LATEX SURG 6.0 SURGEON'S GLOVES KGO CARDINAL HEALTH NOT LEGIBLE

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| O