BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMMODE,3-IN-1,STEEL,FLD,350 LB

    MDR report key: 21304103 · Received February 4, 2025

    Report

    Report Number
    1417592-2025-00054
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    January 3, 2025
    Report Date
    February 4, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    ILS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, HIS WIFE SAT ON THE UNIT WHEN "THE REAR RIGHT LEG BENT CAUSING HER TO FALL TO THE GROUND AND HIT HER HEAD" ON (B)(6) 2025. THE CUSTOMER REPORTED SHE HAS A "HISTORY OF A BRAIN TUMOR", AND HER MOBILITY HAS DECLINED SINCE THE INCIDENT OCCURRED. THE CUSTOMER REPORTED SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 TO HAVE TESTING PREFORMED TO DETERMINE IF ANY SERIOUS INJURY DEVELOPED FROM THE FALL AND IS CAUSING HER REDUCED MOBILITY. THE CUSTOMER REPORTED ON (B)(6) 2025 THAT ALL OF THE IMAGING PERFORMED AT THE HOSPITAL CAME BACK NEGATIVE, BUT SHE IS STILL IN THE HOSPITAL AND WILL BE DISCHARGE TO A "REHAB FACILITY" DUE TO THE DEGRADATION IN MOBILITY. THE CUSTOMER REPORTED THE DEGRADATION IN HIS WIFE'S MOBILITY BEGAN AFTER THE FALL, AND HE BELIEVES THIS IS THE CAUSE OF HER DECLINE. 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, HIS WIFE SAT ON THE UNIT WHEN "THE REAR RIGHT LEG BENT CAUSING HER TO FALL TO THE GROUND AND HIT HER HEAD" ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61022 COMMODE,3-IN-1,STEEL,FLD,350 LB ILS MEDLINE INDUSTRIES, LP

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other