BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XTRA TRAC SHOEC, XLG

    MDR report key: 17743922 · Received September 14, 2023

    Report

    Report Number
    3014421917-2023-00013
    Event Type
    Injury
    Date Received
    September 14, 2023
    Report Date
    October 16, 2023
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXP
    UDI-DI
    30680651692543
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION. A SCAR WAS ISSUED TO HUBEI XINXIN NON-WOVEN CO., LTD THE MANUFACTURER OF THE XTRA TRAC SHOEC, XLG PRODUCT CODE 69254 ON AUGUST 21, 2023. HUBEL XINXIN NON-WOVEN CO., LTD (FDA REGISTRATION 3011547453). 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 PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    SAMPLE FROM CUSTOMER WAS RECEIVED ON (B)(6) 2023. THERE IS ONLY ONE SHOE COVER IN THE BOX. IT IS A RANDOM REPRESENTATIVE SAMPLE PROVIDED BY THE CUSTOMER AND IT IS NOT CERTAIN THAT IT¿S THE SAME BATCH AS THE COMPLAINT LOT. WE OBSERVED THE PRINTED PATTERN ON THE BOTTOM OF THE SHOE COVER, AND THERE WAS NO ABNORMALITY. THE SAMPLE WAS RETURNED TO THE MANUFACTURER (HUBEI XINXIN NON-WOVEN CO) FOR EVALUATION. THE AVERAGE STATIC FRICTION IS (B)(4) AND THE AVERAGE KINETIC FRICTION IS (B)(4). THE RESULTS MEET THE REQUIREMENTS OF SPECIFICATION. CONTRACT MANUFACTURER RESPONDED TO SUPPLIER CORRECTIVE ACTION REQUEST WITH THE FOLLOWING FINDINGS ON SEPTEMBER 28, 2023. LOT NUMBER WAS NOT PROVIDED. WE HAVE REVIEWED THE INSPECTION RECORDS OF THIS PRODUCT 69254 FROM AUGUST 2022 TO AUGUST 2023, AND FOUND NO PROBLEMS SIMILAR TO THE COMPLAINT. THE LAST THREE BATCHES OF FABRIC INSPECTION RECORDS WERE REVIEWED AND PASSED. TWO BATCHES OF 69254 WERE IN THE WAREHOUSE AND EVALUATED. THEIR RESULTS MEET THE SPECIFICATION. A ROOT CAUSE WAS NOT DETERMINED. THE CUSTOMER WAS ASKED ABOUT SPECIFIC DETAILS OF THE COMPLAINT, SUCH AS THE ENVIRONMENT DURING USE AND THERE WAS NO FEEDBACK PROVIDED. 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 PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE GRIP TAPE ON THE BOTTOM OF THE COVERS IS SMOOTH AND NOT TACKY. STAFF MEMBER SLIPPED ON A TEXTURED RAMP WHILE WEARING THESE COVERS AND WAS INJURED. ADDITIONAL DETAILS REGARDING INJURY WERE REQUESTED ON AUGUST 18 AND AUGUST 23, 2023. NO RESPONSE HAS BEEN RECEIVED TO-DATE.

    Description of Event or Problem · 0

    THE SITE REACHED OUT TO THE COMPLAINT REPORTER FOR ADDITIONAL INCIDENT DETAILS ON AUGUST 18, AUGUST 22, AND AUGUST 23. THE CUSTOMER HAS NOT RESPONDED TO REQUESTS FOR ADDITIONAL DETAILS TO SUPPORT INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2282955 XTRA TRAC SHOEC, XLG APPAREL HEADWEAR/FOOTWEAR FXP O&M HALYARD, INC. 69254 UNKNOWN 30680651692543

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other