BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURPLE NITRILE* EXAM GLOVE

    MDR report key: 6912413 · Received October 3, 2017

    Report

    Report Number
    3011270181-2017-00007
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    February 19, 2016
    Report Date
    September 14, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    LZC
    UDI-DI
    30680651550829
    PMA / PMN Number
    K113423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL GLOVE INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. IMAGES PROVIDED OF THE SKIN GRAFT SHOW THAT THE INJURY APPEARS TO BE ABOVE THE SKIN AREA THE GLOVE NORMALLY COVERS. ADDITIONALLY, THE GLOVE IS NOT INTENDED TO PROVIDE A THERMAL BARRIER. ALL INFORMATION REASONABLY KNOWN AS OF 02OCT2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER WAS POURING BOILING NITRIC ACID INTO A BEAKER AND WITHOUT WARNING A CHEMICAL REACTION OCCURRED CAUSING ACID TO SPILL ONTO THE WRIST. THE BOILING ACID BURNED THROUGH THE PURPLE NITRILE GLOVES CAUSING THIRD-DEGREE BURNS, WHICH REQUIRED A SKIN GRAFT USING SKIN FROM THE CUSTOMER¿S RIGHT LEG. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690932 PURPLE NITRILE* EXAM GLOVE EXAM GLOVES NITRILE LZC HALYARD HEALTH 55082 UNKNOWN 30680651550829

    Patients

    Seq Age Sex Outcome Treatment
    1 Other