BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVER,SHOE,SPUNBOND,NONSKID,BLUE,XLG

    MDR report key: 22848817 · Received August 20, 2025

    Report

    Report Number
    1417592-2025-00397
    Event Type
    Injury
    Date Received
    August 20, 2025
    Date of Event
    July 21, 2025
    Report Date
    September 29, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    FXP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO H6: INVESTIGATION FINDINGS (C). UPDATE TO H6: INVESTIGATION CONCLUSIONS (D).

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, A TEAM MEMBER WAS WALKING AND MAKING A SLIGHT TURN WHEN THEY SLIPPED AND FELL RESULTING IN A BROKEN PATELLA REQUIRING SURGERY. THE CUSTOMER REPORTED THAT THERE WAS NO LIQUID ON THE VINYL FLOOR AT THE TIME OF THE INCIDENT. THE TEAM MEMBER IS OFF WORK AND REQUIRED SURGERY ON (B)(6) 2025 TO REPAIR THE PATELLA. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, A TEAM MEMBER WAS WALKING AND MAKING A SLIGHT TURN WHEN THEY SLIPPED AND FELL RESULTING IN A BROKEN PATELLA REQUIRING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243969 COVER,SHOE,SPUNBOND,NONSKID,BLUE,XLG FXP MEDLINE INDUSTRIES, LP 10825030032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other