BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUBBY BEDS

    MDR report key: 24169039 · Received January 23, 2026

    Report

    Report Number
    3016541541-2026-00005
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    December 25, 2025
    Report Date
    January 23, 2026
    Manufacturer
    SENSORY MEDICAL INC.
    Product Code
    OYS
    UDI-DI
    00860007550249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2026, THE PARENT CONTACTED SENSORY MEDICAL STATING THEY PLAN TO DISCONTINUE USE OF THE BED. THE DURABLE MEDICAL EQUIPMENT PROVIDER (DME) IS SCHEDULED TO PICK UP THE BED. SENSORY MEDICAL HAS REQUESTED RETURN OF THE CANOPY FOR INSPECTION ON JANUARY 8TH AND 12TH 2026. THE LOT FOR THE CANOPY IS 250102M02. REVIEW OF MANUFACTURING RECORDS CONFIRM THAT ALL IN PROCESS AND FINAL INSPECTIONS WERE PERFORMED AND PASSED. MULTIPLE STATEMENTS ARE MADE IN THE CUBBY BED USER MANUAL REGARDING SAFE USE OF THE BED TO PREVENT INJURIES AND OTHER SAFETY CONCERNS. PAGE 3 OF THE USER MANUAL CONTAINS MULTIPLE WARNINGS, INCLUDING: "CUBBY MUST HAVE 12 INCHES OF SPACE IN BETWEEN THE PRODUCT AND SOLID OBJECTS." "DO NOT USE THIS PRODUCT IF YOU DO NOT UNDERSTAND OR CANNOT FOLLOW THE ACCOMPANYING WARNINGS AND INSTRUCTIONS." "DO NOT ALLOW ANYONE TO CLIMB OR HANG FROM THE PRODUCT." "YOU ARE RESPONSIBLE FOR PROVIDING ADULT SUPERVISION WHILE USING THIS PRODUCT." "NEVER LEAVE PATIENT USER UNATTENDED FOR EXTENDED PERIODS OF TIME WITHOUT MONITORING AND SENSORY STIMULATION." "NEVER PLACE BED NEAR WINDOWS WHERE CORDS FROM BLINDS OR DRAPES MAY STRANGLE A CHILD." CUBBY BED INVESTIGATION HAS CONCLUDED NO MALFUNCTION AND THE PARENT HAD THE PRODUCT CLOSER TO THE WINDOW THAN SPECIFIED WITHIN LABELING.

    Description of Event or Problem · 0

    PER PARENT, HER SON WAS RUNNING ACROSS HIS BED, TRIPPED AND FELL. SHE SAID HER CHILD'S HEAD HIT THE CANOPY WALL, WHICH WAS PUSHED UP AGAINST THE WINDOW AT THE TIME OF THE EVENT. PER PARENT THE CHILD MADE CONTACT WITH THE WINDOWSILL, LEADING TO A LACERATION. THE COMPLAINANT STATED THIS EVENT OCCURRED ON DECEMBER 25TH, 2025. THE PARENT WOULD LIKE TO HAVE THE BED RETURNED. PER MEDICAL REPORT BY (B)(6) DEPARTMENT DATED ON (B)(6) 2025, THE CHILD HAD A 3CM LINEAR LACERATION TO THE RIGHT FOREHEAD ON THE LATERAL ASPECT. THE REPORT SAYS THE LACERATION EXTENDS THROUGH THE GALEA (TISSUE SURROUNDING THE SKULL), NO SKULL FRACTURE OR SKULL LAXITY, STEP-OFFS (DEPRESSIONS), OR CREPITUS (SOUNDS INDICATING FRACTURE). THE REPORT SAYS THE CHILD HAS BEEN ACTING NORMAL WITHOUT ANY LOSS OF CONSCIOUSNESS, VOMITING OR GAIT/BEHAVIORAL DISTURBANCE. THE PARENT PROVIDED THREE IMAGES, TWO SHOWING THE OPEN LACERATION, THE LAST SHOWING THE LACERATION CLOSED WITH 18 STITCHES. PER PARENT, NO MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233019 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL INC. 250102M02 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Required Intervention