BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD IMPERVIOUS OPEN-BACK GOWN BLUE KNIT CUFFS LARGE

    MDR report key: 24394019 · Received February 19, 2026

    Report

    Report Number
    3014421917-2026-00004
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    January 21, 2026
    Report Date
    February 19, 2026
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    OEA
    UDI-DI
    30680651694554
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) UNUSED REPRESENTATIVE SAMPLE WAS RECEIVED AND EVALUATED. NO ABNORMALITIES WERE NOTED, GOWN MET PRODUCT SPECIFICATIONS. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE HALYARD IMPERVIOUS OPEN-BACK GOWN BLUE KNIT CUFFS LARGE. THE PART NUMBER 69455 IS CONTRACT MANUFACTURED BY ANDERSEN INDUSTRIES CO. LTD., (FDA REGISTRATION NUMBER 3015960676). SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON JANUARY 30, 2026. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT LOT WAS REVIEWED IN ITS ENTIRETY, AND NO ABNORMALITIES OR DEVIATIONS WERE IDENTIFIED. THE PRODUCT MET ALL ESTABLISHED INSPECTION AND RELEASE CRITERIA AT THE TIME OF MANUFACTURE. THERE HAVE BEEN NO CHANGES TO THE PRODUCT DESIGN, RAW MATERIALS, OR MANUFACTURING PROCESSES ASSOCIATED WITH PRODUCT. ADDITIONALLY, THE CONTRACT MANUFACTURER CONFIRMED THAT NO NEW PERSONNEL WERE ASSIGNED TO THE PRODUCTION LINE DURING THE MANUFACTURE OF THIS LOT. THIS IS THE FIRST COMPLAINT OF THIS NATURE ASSOCIATED WITH THIS GOWN. A REVIEW OF COMPLAINT DATA CONFIRMS THAT THERE IS NO ADVERSE TREND RELATED TO THIS ISSUE. 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

    ON (B)(6), A STAFF MEMBER EXPERIENCED STRIKETHROUGH ON THE FOREARM THAT RESULTED IN A CHEMICAL BURN. THE EMPLOYEE WASHED THE AFFECTED AREA WITH MILD SOAP AND WATER AND COMPLETED THE REMAINDER OF THE SHIFT. THE INCIDENT WAS REPORTED TO EMPLOYEE HEALTH; HOWEVER, TO THE MANAGER¿S KNOWLEDGE, THE EMPLOYEE WAS NOT PRESCRIBED ANY ADDITIONAL TREATMENT OR FURTHER EVALUATION. THE EMPLOYEE RETURNED TO WORK ON (B)(6) WITH NO MEDICAL TREATMENT REPORTED. AT THE TIME OF THE INCIDENT, THE EMPLOYEE WAS WEARING MEDLINE GLOVES. THE BURN OCCURRED ABOVE THE GLOVE LINE. IT IS CURRENTLY UNCLEAR WHETHER THE REACTION WAS CAUSED BY THE CHEMICAL IN USE, THE GOWN SLEEVE, OR THE GLOVES. THE EMPLOYEE IS KNOWN TO HAVE A GENERAL ALLERGY SENSITIVITY. THE CHEMICAL BEING USED AT THE TIME OF THE OCCURRENCE WAS ECOLAB MULTI-ENZYMATIC CONCENTRATED DETERGENT. THE MANAGER STATED THE FACILITY HAS USED THE SAME GOWN STYLE FOR MORE THAN EIGHT YEARS. STAFF MEMBERS CHANGE GOWNS THREE TIMES DURING AN EIGHT-HOUR SHIF; TWICE FOR 15-MINUTE BREAKS AND ONCE FOR A LUNCH BREAK. EMPLOYEES IN THIS AREA ARE ROUTINELY EXPOSED TO HEAVY FLUID LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449383 HALYARD IMPERVIOUS OPEN-BACK GOWN BLUE KNIT CUFFS LARGE PROTECTIVE APPAREL OEA O&M HALYARD, INC. 69455 KA25203005 30680651694554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown