BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HG FULL BOOT COVER

    MDR report key: 19469310 · Received June 5, 2024

    Report

    Report Number
    3014421917-2024-00016
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Report Date
    July 17, 2024
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    LYU
    UDI-DI
    30680651696725
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BELOW CORRECTIVE AND PREVENTATIVE ACTIONS WERE IMPLEMENTED BY SUPPLIER SINCE APRIL 26TH, 2023, AS A RESULT OF PRIOR SIMILAR COMPLAINT. THERE WAS NO LOT NUMBER OR SAMPLES RECEIVED BY THE COMPLAINANT, THEREFORE, O&M IS NOT SURE IF THE COMPLAINT PRODUCT WAS MANUFACTURED BEFORE OR AFTER THESE CORRECTIVE ACTIONS WERE IMPLEMENTED. THE MANUFACTURING SITE HAS TAKEN THE FOLLOWING ACTIONS: 1. UPDATED THE WORK INSTRUCTION TO ADD REQUIREMENTS AND VISUAL PHOTO INSTRUCTIONS FOR STICKING THE FOAM STRIPS. 2. INFORMED WORKERS ABOUT THE CUSTOMER COMPLAINT TO INCREASE AWARENESS. 3. INCREASED INSPECTION FREQUENCY OF THE PASTING PROCESS FROM TWICE A DAY TO FOUR TIMES A DAY. 4. CREATED A FOLDING DIAGRAM. 5. RETRAINED TEAMMATES ON NEW WORK INSTRUCTIONS AND DIAGRAM. 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

    THE PRODUCT INVOLVED IN THIS EVENT IS AVAILABLE FOR EVALUATION BUT HAS NOT BEEN RETURNED AT THE TIME OF THIS REPORT. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE COMPLAINT PRODUCT. THE PRODUCT IS CONTRACT MANUFACTURED BY HUBEI XINXIN NON-WOVEN CO., LTD (FDA REGISTRATION NUMBER 3011547453). A SCAR WAS ISSUED TO THE CONTRACT MANUFACTURER ON MAY 9, 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. H3 OTHER TEXT : DEVICE NOT RETURNED

    Description of Event or Problem · 0

    THE BOOT COVERS HAVE A BLACK STRIP ON THE BOTTOM THAT COMES OFF. THE STRIP HELPS PREVENT SLIPPING WHILE WALKING IN THE BOOT COVERS. STAFF ARE WORRIED ABOUT POTENTIALLY FALLING AND INJURYING THEMSELVES OR PATIENTS WHILE WEARING THESE IN AN OR SETTING WHERE FLUIDS ARE PRESENT. THERE ARE NO INJURIES REPORTED CURRENTLY BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523236 HG FULL BOOT COVER PROTECTIVE APPAREL LYU O&M HALYARD, INC. 69672 UNKNOWN 30680651696725

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown