BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUBBY BEDS

    MDR report key: 24027719 · Received January 9, 2026

    Report

    Report Number
    3016541541-2026-00001
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    December 10, 2025
    Report Date
    January 9, 2026
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    OYS
    UDI-DI
    00860007550249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT REFUSED A REPLACEMENT. SENSORY MEDICAL HAS FOLLOWED UP ON DECEMBER 11 (CALL AND EMAIL) AND 16 (EMAIL) REQUESTING ADDITIONAL INFORMATION. THE CANOPY LOT IS 231019M11. REVIEW OF THE MANUFACTURING RECORDS CONFIRMS 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 SAFETY CONCERNS. IN THE WARNINGS SECTION ON PAGE 3: "WARNING: FAILURE TO FOLLOW WARNINGS, INFORMATION AND INSTRUCTIONS COULD RESULT IN SERIOUS INJURY OR DEATH (KEEP INSTRUCTIONS, WARNINGS, AND PRODUCT INFORMATION FOR FUTURE REFERENCE." "DO NOT USE THIS PRODUCT IF YOU DO NOT UNDERSTAND OR CANNOT FOLLOW THE ACCOMPANYING WARNINGS AND INSTRUCTIONS." "DO NOT LET ANYONE CLIMB OR HANG FROM THE PRODUCT" "DO NOT LET ANYONE TO JUMP ON OR AGAINST THE PRODUCT." "YOU ARE RESPONSIBLE FOR PROVIDING ADULT SUPERVISION WHILE USING THIS PRODUCT." "USE THE MAINTENANCE CHECKLIST IN THE MANUAL TO INSPECT THE CANOPY, SEAMS, ZIPPERS, ELECTRONIC ACCESSORIES, CORDS, METAL FRAME, SCREWS, SLATS, LOCKS, AND SAFETY SHEETS EVERY 30 DAYS." "IF ANY DAMAGE IS PRESENT, IMMEDIATELY DISCONTINUE USE AND CONTACT CUBBY FOR REPAIR OR REPLACEMENT." "CHECK THIS PRODUCT FOR DAMAGED HARDWARE, LOOSE JOINTS, LOOSE BOLTS OR OTHER FASTENERS, MISSING PARTS OR SHARP EDGES BEFORE AND AFTER ASSEMBLY AND FREQUENTLY DURING USE. SECURELY TIGHTEN LOOSE BOLTS AND OTHER FASTENERS." "DO NOT USE PRODUCT IF ANY PARTS ARE MISSING, DAMAGED OR BROKEN. CONTACT CUBBY FOR REPLACEMENT PARTS AND INSTRUCTIONAL LITERATURE IF NEEDED. DO NOT SUBSTITUTE PARTS." "NEVER LEAVE PATIENT USER UNATTENDED FOR LONG PERIODS OF TIME WITHOUT MONITORING AND SENSORY STIMULATION." ADDITIONAL INVESTIGATION IS NEEDED, AND SENSORY MEDICAL'S ROOT CAUSE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    PER PARENT, HER AUTISTIC SON CLIMBED THE OUTSIDE OF THE BED AND ONTO THE ROOF, FELL OFF, AND BROKE HIS WRIST. PER PARENT, DURING THIS EVENT, HE BROKE THE SLEEVE ZIPPER ON THE LONG SIDE OF THE BED AND EVEN THOUGH THE TWO FRAME/SLEEVE STRAPS WERE IN PLACE, THERE WAS ENOUGH SPACE FOR HIM TO FALL OFF THE BED, BUMP HIS HEAD AND NOSE AND BREAK HIS WRIST. THE PARENT SHARED THAT THE EVENT OCCURRED WHEN THE CHILD WAS IN HIS ROOM AND NOT SECURED IN THE BED. THE PARENT STATED SHE TOOK HER SON TO THE EMERGENCY ROOM AND LATER TO AN ORTHOPEDIC PHYSICIAN. PER PARENT HER SON'S WRIST WILL HEAL WITHOUT A CAST. A PICTURE OF PART OF THE CHILD'S MEDICAL RECORD WAS PROVIDED. PER PICTURE OF MEDICAL RECORD DATED 12/10/2025, THE INJURY WAS CONFIRMED AS A BUCKLE FRACTURE OF DISTAL END OF RIGHT RADIUS. PARENT STATED SHE HAD DISASSEMBLED THE CUBBY BED CANOPY BUT WAS CONTINUING TO USE THE MATTRESS AND FRAME. SENSORY MEDICAL ADVISED THAT SHE DISCONTINUE USE OF THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89936 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC. 231019M11 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male Other