BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 21315649 · Received February 5, 2025

    Report

    Report Number
    1417592-2025-00057
    Event Type
    Injury
    Date Received
    February 5, 2025
    Date of Event
    January 7, 2025
    Report Date
    February 5, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    ILS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, "THE FRONT CROSSBAR ON THE COMMODE CAME OUT OF THE HOLDING SLOT CAUSING THE LEFT LEG TO COME OFF AND THE CHAIR TO TIP BACKWARDS" WHILE SHE WAS SITTING ON IT CAUSING HER TO FALL. THE CUSTOMER REPORTED SHE DEVELOPED BRUISING AND SWELLING ON BOTH LEGS, ANKLES, AND HIP. THE CUSTOMER REPORTED SHE HAD AN XRAY PERFORMED ON HER ANKLE, AND IT RESULTED NEGATIVE FOR A "BREAK", BUT HER DOCTOR DIAGNOSED HER WITH A "SPRAIN". THE CUSTOMER REPORTED SHE WAS PRESCRIBED "HYDROCORTISONE" FOR THE PAIN. THE CUSTOMER REPORTED THAT HER INJURIES ARE NOW BEGINNING TO HEAL. 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, "THE FRONT CROSSBAR ON THE COMMODE CAME OUT OF THE HOLDING SLOT CAUSING THE LEFT LEG TO COME OFF AND THE CHAIR TO TIP BACKWARDS" WHILE SHE WAS SITTING ON IT CAUSING HER TO FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53074 COMMODE,3-IN-1,STEEL,FLD,350 LB ILS MEDLINE INDUSTRIES, LP 88523070002

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other