BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUBBY BEDS

    MDR report key: 23408505 · Received October 28, 2025

    Report

    Report Number
    3016541541-2025-00075
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    September 21, 2025
    Report Date
    October 28, 2025
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    OYS
    UDI-DI
    00860007550249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, SENSORY MEDICAL DOES NOT HAVE EVIDENCE THAT THE INJURY INCURRED IS RELATED TO MALFUNCTION OF THE CANOPY BED.. SENSORY MEDICAL CONFIRMED THAT SAFETY FEATURES WERE NOT IN USE. SENSORY MEDICAL HAS REQUESTED THE MEDICAL RECORDS AND DISCHARGE PAPERWORK RELATED TO THE CHILD'S INJURY. 231012M07 IS THE LOT OF THE CANOPY. REVIEW OF THE MANUFACTURING RECORDS CONFIRMS ALL INSPECTIONS WERE 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." "YOU ARE RESPONSIBLE FOR PROVIDING ADULT SUPERVISION WHILE USING THIS PRODUCT." "DO NOT LET ANYONE CLIMB OR HAND FROM THE PRODUCT" "DO NOT LET ANYONE TO JUMP ON OR AGAINST THE PRODUCT." "NEVER LEAVE PATIENT USER UNATTENDED FOR LONG PERIODS OF TIME WITHOUT MONITORING AND SENSORY STIMULATION." PAGE 5 CONTAINS A PARTS LIST, WHICH INCLUDES THE LOCKS. PAGE 13, STEP 12 INSTRUCTS ON USE OF THE S-CLIPS TO SECURE THE DOOR ZIPPERS. PAGE 15, ASSEMBLY AND CARE FAQS, INSTRUCTS TO USE THE S-CLIPS TO SECURE THE DOOR ZIPPERS CLOSED TO PREVENT USER ELOPEMENT. PAGE 16, HOW TO USE YOUR CUBBY BED, INSTRUCTS ON USE OF THE S-CLIPS TO SECURE THE DOOR ZIPPERS. ADDITIONAL INVESTIGATION IS NEEDED, AND SENSORY MEDICAL'S ROOT CAUSE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    PER PARENT, WHEN HER 4-YEAR OLD AUTISTIC SON EXITED THE BED THROUGH THE UNZIPPED FRONT DOOR ON THE EVENING OF (B)(6) 2025, HE SLIPPED, FELL AND BROKE HIS RIGHT SHOULDER. PARENT STATED THE DOORS WERE OPEN AND UNZIPPED AND THEY WERE NOT USING S-CLIPS TO SECURE THE ZIPPERS CLOSED. THE COMPLAINANT SHARED THEY MEASURED THE HEIGHT OF THE FALL AT 20 INCHES. SHE SAID SHE TOOK HER SON TO THE EMERGENCY ROOM ON (B)(6) 2025 AND LATER TO AN ORTHOPEDIC SPECIALIST ON (B)(6) 2025. THE FAMILY HAS BEEN USING THE BED APPROXIMATELY A YEAR AND SAID THEY ARE STILL USING THE CUBBY BED. SENSORY MEDICAL ADVISED THE FAMILY TO CONTINUE TO USE THE BED ONLY WITH THE DOORS SECURED WITH S-CLIPS. THE PARENT STATED THEY HAVE THE S-CLIPS BUT HER CHILD BECOMES DISTRAUGHT WHEN CLOSED INTO THE BED. SENSORY MEDICAL ADVISED TO SECURE JUST THE MESH DOOR SO HE IS ABLE TO SEE OUT AND TO ROLL UP AND SECURE THE OUTER DOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744940 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC. 231012M07 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Other