BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRA TRAC SHOEC, XLG

    MDR report key: 20474939 · Received October 17, 2024

    Report

    Report Number
    3014421917-2024-00009
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Report Date
    November 20, 2024
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXP
    UDI-DI
    30680651692543
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT TWO. ON OCT 16, 2024, WE RECEIVED THE RETURNED SAMPLE OF 69254. THERE WAS 1 SHOE COVER IN THE BAG. WE PERFORMED THE VISUAL INSPECTION OF THE BOTTOM PATTERN AND FOUND NO INCOMPLETE PRINTED PATTERN OR VISIBLE INCONSISTENCY OF GLUE. WE SENT SAMPLE TO LAB FOR STATIC AND KINETIC FRICTION TEST. ACCORDING TO HUBEI XINXIN NON-WOVEN CO., LTD INTERNAL FABRIC SPECIFICATION, THE STANDARD OF STATIC AND KINETIC FRICTION SHOULD BE GREATER THAN 0.6. THIS SAMPLE WAS FOUND TO MEET SPECIFICATION. BASED ON RETURNED SAMPLE INVESTIGATION AND RETAINED SAMPLE INVESTIGATION, ALL STATIC AND KINETIC FRICTION TEST RESULTS WERE FOUND TO MEET SPECIFICATION. A WEAR TEST WAS CONDUCTED, WEARING SHOE COVER IN NORMAL OFFICE ENVIRONMENT, PRODUCTION ENVIRONMENT, AND LABORATORY ENVIRONMENT. EACH TEST LASTS ABOUT HALF AN HOUR, NONE OF THE WEARERS FOUND SHOE COVER TO BE SLIPPERY AND THE GLUE COATING DID NOT COME OFF. DEVICE HISTORY RECORD REVIEW, INCLUDING ALL INSPECTION RECORDS WAS CONDUCTED. ALL RESULTS WERE FOUND TO BE WITHIN RANGE WITH NO ABNORMALITIES DISCOVERED. BASED ON ABOVE INVESTIGATION, A ROOT CAUSE WAS NOT DETERMINED; HOWEVER, WE WILL CONTINUE TRACKING AND TRENDING OF COMPLAINTS TO DETERMINE IF CORRECTIVE ACTIONS ARE WARRANTED. 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

    INCIDENT ONE OF TWO. THE PRODUCT INVOLVED IN THE EVENT IS AVAILABLE FOR RETURN BUT HAS NOT BEEN RECEIVED YET. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE HALYARD, X-TRA TRACTION, SHOE COVER, XL, BLUE. THE COMPLAINT COMPONENT HALYARD, X-TRA TRACTION, SHOE COVER, XL, BLUE, PART NUMBER: 69254 IS CONTRACT MANUFACTURED BY HUBEI XINXIN NON-WOVEN CO., LTD (FDA REGISTRATION NUMBER: (B)(4). SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON OCTOBER 8, 2024. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE MANUFACTURER. 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

    INCIDENT ONE. THERE WERE 2 WORKPLACE INJURIES REPORTED. THE CUSTOMER REPORTED THE TRACTION WAS INSUFFICIENT. THESE WERE NOT SERIOUS INJURIES; NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO LOST TIME FROM WORK, ONLY BRUISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276832 XTRA TRAC SHOEC, XLG XTRA TRAC SHOEC, XLG FXP O&M HALYARD, INC. 69254 HX24118370 30680651692543

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown