BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRA TRAC SHOEC, XLG

    MDR report key: 19079230 · Received April 10, 2024

    Report

    Report Number
    3014421917-2024-00003
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Report Date
    June 3, 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO LOT OR SAMPLE WAS AVAILABLE FOR INVESTIGATION. 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 (B)(4). A SCAR WAS ISSUED TO THE CONTRACT MANUFACTURER ON MARCH 21, 2024. THE CONTRACT MANUFACTURER REVIEWED ALL OUTGOING INSPECTION RECORDS APRIL 2023 - MARCH 2024. NO PROBLEMS WERE NOTED. THE CONTRACT MANUFACTURER RANDOMLY SELECTED ONE PRODUCT BATCH FROM WAREHOUSE TO TEST. THEY PERFORMED A PHYSICAL ASTM TEST, AND A WEAR PERFORMANCE TEST OVER 4-HOUR TIME PERIOD. ALL TEST RESULTS WERE CONFORMING. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP (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 A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE X-TRA TRACTION* SHOE COVER, XL, BLUE. THE COMPLAINT COMPONENT X-TRA TRACTION* SHOE COVER, XL, BLUE, PART NUMBER 69254 IS CONTRACT MANUFACTURED BY HUBEI XINXIN NON-WOVEN CO., LTD (FDA REGISTRATION NUMBER 3011547453). A SUPPLIER CORRECTIVE ACTION (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON 21MAR2024. 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 A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE PROVIDER WAS WEARING SHOE COVER OUTSIDE OF THE OPERATING ROOM AND SLIPPED. THE PROVIDER DID NOT REPORT FALLING AND THERE WAS NO INJURY TO THE PROVIDER AS A RESULT OF SLIPPING WEARING THE SHOE COVER. THE PROVIDER NOTED POOR TRACTION AND DESIGN OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407907 XTRA TRAC SHOEC, XLG PROTECTIVE APPAREL FXP O&M HALYARD, INC. 69254 UNKNOWN 30680651692543

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown