BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR SPA

    MDR report key: 24562991 · Received March 10, 2026

    Report

    Report Number
    1922538-2026-00001
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 10, 2026
    Manufacturer
    PENNER PATIENT CARE, INC
    Product Code
    ILJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOT ENOUGH INFORMATION TO FORM ANY POSSIBLE CONFIRMATION OF EQUIPMENT MALFUNCTION OR MISUSE OF OPERATING PROCEDURES. THEIR MAINTENANCE PERSONNEL CLAIMED AFTER LOCK OUT TAG OUT THAT EVERYTHING PERFORMED AS IT SHOULD HAVE.

    Description of Event or Problem · 0

    RESIDENT WAS BEING ASSISTED BY A CNA IN THE TUB ROOM FOR A SHOWER. NA REPORTS AFTER THE SHOWER SHE WAS DRAINING THE WATER AND NOTICED BLOOD ON THE RESIDENT'S HEEL. AFTER FURTHER INSPECTION, SHE NOTICED BLOOD WAS COMING FROM RESIDENT'S RIGHT FOOT 3RD TOE AND NOTED THE TOE WAS PARTIALLY AMPUTATED POSTERIORLY. NURSING ASSISTANT DENIED ANY KNOWN TRAUMA. THE RESIDENT DENIED ANY KNOWN TRAUMA. THE RESIDENT WAS SENT TO THE ED FOR EVALUATION. LOCK OUT/TAG OUT COMPLETED ON THE SPA TUB. IT WAS INSPECTED BY OUR MAINTENANCE DEPARTMENT AND WAS FOUND TO BE FUNCTIONING APPROPRIATELY, NO ROUGH OR SHARP EDGES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388614 CONTOUR SPA BATHING SPA ILJ PENNER PATIENT CARE, INC 383000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 125 YR Male Other