BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLV EXAM PF ESTEEM NEU-THERA NITRILE XS

    MDR report key: 2906934 · Received January 10, 2013

    Report

    Report Number
    1423537-2013-00003
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    November 27, 2012
    Report Date
    January 10, 2013
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LZC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED, THEREFORE THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ABNORMALITIES WERE NOTED. HISTORICAL TRENDING FOUND THIS TO BE THE FIRST REPORTED INCIDENT OF THIS LOT, CATALOG NUMBER, AND FAILURE MODE. SAMPLES WERE PROVIDED, AND VISUAL INSPECTION OF THE RETURNED SAMPLES FOUND NO ABNORMALITIES. BASED ON THE COMPLAINT DESCRIPTION AND ON THE TESTING CONDUCTED OF THE RETURNED SAMPLES, THIS APPEARS TO BE AN ISOLATED INCIDENT. THE ROOT CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED. THE SUPPLIER HAS BEEN APPRISED OF THIS REPORTED INCIDENT AND WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS INCLUDING THEIR MANAGEMENT OF THE GLOVE FORMERS. WE WILL CONTINUE TO MONITOR FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 1

    A PHLEBOTOMIST HAD WHAT APPEARED TO BE TINY GLASS FRAGMENTS EMBEDDED IN HER HANDS. SHE SAW HER PRIMARY CARE PROVIDER ON (B)(6) 2012. SHE DID NOT IMMEDIATELY SUSPECT THE GLOVES. HER PRIMARY CARE PROVIDER SUGGESTED THAT THE GLOVES COULD BE THE PROBLEM AND TO TRY AN ALTERNATIVE. HE RECOMMENDED REFERRAL TO DERMATOLOGY IF THE PROBLEM WAS NOT ABLE TO BE RESOLVED BY CHANGING GLOVES. THE PHLEBOTOMIST CHANGED TO A NEW LOT NUMBER WHICH WAS OKAY. HER HANDS ARE BETTER ALTHOUGH THERE ARE STILL SOME SCARS. SHE DID NOT FEEL IT NECESSARY TO SEE DERMATOLOGY AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13434 GLV EXAM PF ESTEEM NEU-THERA NITRILE XS GLOVE, PATIENT EXAMINATION, SPECIALTY LZC CARDINAL HEALTH 5W11K001

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other