BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALYARD AQUASOFT POWDER FREE NITRILE EXAM GLOVE M

    MDR report key: 21023764 · Received December 26, 2024

    Report

    Report Number
    3014421917-2024-00023
    Event Type
    Injury
    Date Received
    December 26, 2024
    Date of Event
    November 26, 2024
    Report Date
    February 21, 2025
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    LZC
    UDI-DI
    20680651476368
    PMA / PMN Number
    K173942
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS EVENT IS NOT AVAILABLE FOR EVALUATION. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE COMPLAINT PRODUCT 47636, HALYARD AQUASOFT POWDER FREE NITRILE EXAM GLOVE. THE PRODUCT IS CONTRACT MANUFACTURED BY CENTRAL MEDICARE SDN BHD (FDA REGISTRATION NUMBER 3008253024). A SCAR WAS ISSUED TO THE CONTRACT MANUFACTURER ON DECEMBER 17, 2024. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY

    Additional Manufacturer Narrative · 0

    NO COMPLAINT SAMPLE WAS RECEIVED. CUSTOMER WAS UNABLE TO CONFIRM COMPLAINT LOT HOWEVER THEY DID INDICATE IT WAS A SIZE MEDIUM. MANUFACTURER FOUND THREE POTENTIAL LOT NUMBERS THAT HAD SHIPPED TO CUSTOMER. THE DHR FOR THESE WAS REVIEWED, NO ABNORMALITIES WERE DISCOVERED. FIVE RETAINED SAMPLES WERE TESTED FOR RESIDUAL POWDER CONTENT, RESULTS WERE WITHIN SPECIFICATION. TEN SAMPLES FROM EACH POTENTIAL COMPLAINT LOT WERE SENT TO AN EXTERNAL LABORATORY FOR RESIDUAL ACCELERATOR TESTING, NO RESIDUAL ACCELERATOR WAS DETECTED. FIVE OFFICE STAFF PERFORMED A WEAR TEST UTILIZING RETAINED SAMPLES, NO IRRITATION OR REACTION WAS OBSERVED. THERE WERE NO CHANGES IN RAW MATERIALS USED, COMPOUNDING FORMULATION OR PRODUCTION PROCESSES. ALL MATERIALS WERE WITHIN SPECIFICATION FOR THE THREE POTENTIAL COMPLAINT LOTS. A ROOT CAUSE WAS NOT ESTABLISHED. COMPLAINT EVALUATION FINDS THERE IS NO POSITIVE TREND OR UPWARD SHIFTS FOR THIS COMPLAINT TYPE FOR GLOVE FAMILY IN THE PAST TWELVE MONTHS ANALYZED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THERE WAS ONE EMPLOYEE THAT SHOWED SIGNS OF CONTACT DERMATITIS AFTER USING THE BLUE NITRILE GLOVES. SHE DEVELOPED SWOLLEN LIPS, TINGLING AND HAD COMPLAINTS OF SHORTNESS OF BREATH AND THROAT TIGHTENING THAT WAS AUDIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966736 HALYARD AQUASOFT POWDER FREE NITRILE EXAM GLOVE M NITRILE EXAM GLOVES LZC O&M HALYARD, INC. 47636 UNKNOWN 20680651476368

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other