BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUBBY BEDS

    MDR report key: 23881753 · Received December 23, 2025

    Report

    Report Number
    3016541541-2025-00092
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    October 13, 2025
    Report Date
    December 23, 2025
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    OYS
    UDI-DI
    00860007550249
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL HAS FOLLOWED UP ON DECEMBER 3, 9, 17, 19, 2025 VIA EMAIL TO REQUEST MEDICAL RECORDS AND PICTURES OF THE DAMAGE AS REQUESTED DURING THE PHONE CALL ON DECEMBER 3, 2025. THE LOT FOR THE CANOPY IS 241010M10. REVIEW OF MANUFACTURING RECORDS CONFIRM THAT ALL IN PROCESS AND FINAL INSPECTIONS WERE PERFORMED AND PASSED. THE PARENT STATED SHE PLANS TO DISCONTINUE USE OF THE BED. MULTIPLE STATEMENTS ARE MADE IN THE CUBBY BED USER MANUAL REGARDING SAFE USE OF THE BED TO PREVENT ELOPEMENT AND OTHER SAFETY CONCERNS. PAGE 3 OF THE USER MANUAL CONTAINS MULTIPLE WARNINGS, INCLUDING: "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." "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 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 MUST HAVE 12 INCHES OF SPACE IN BETWEEN THE PRODUCT AND SOLID OBJECTS." "OPENINGS IN AND BETWEEN BED PARTS CAN ENTRAP THE HEAD AND THE NECK." "TO AVOID DANGEROUS GAPS DO NOT USE THIS PRODUCT WITHOUT THE SAFETY SHEETS COMPLETELY ZIPPED AND LOCKED IN PLACE TO THE SIDEWALL. SAFETY SHEET WITH LOCK IN PLACE IS ALWAYS REQUIRED." PAGE 5 CONTAINS A PARTS LIST, WHICH INCLUDES THE LOCKS, CLIPS, AND SAFETY SHEETS. PAGE 11 INSTRUCTS TO SECURE THE SAFETY SHEET ZIPPER TO THE LOOP ON THE CANOPY WITH THE LOCK TO PREVENT THE PATIENT USER FROM REMOVING THE SHEET. DO NOT USE THE PRODUCT WITHOUT THE SAFETY SHEETS ZIPPED AND LOCKED IN PLACE. 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 15 ASSEMBLY + CARE FAQ'S INCLUDES DESCRIPTION AND USE OF THE LOCKS ON THE SAFETY SHEETS AND THE TECHNOLOGY HUB ZIPPERS AND S-CLIPS ON THE DOORS. PAGE 16, HOW TO USE YOUR CUBBY BED, INSTRUCTS ON USE OF THE S-CLIPS TO SECURE THE DOOR ZIPPERS. ON PAGE 22 INCLUDES A MONTHLY MAINTENANCE CHECKLIST, ONE CHECK IS: "SAFETY SHEET FABRIC, CORD LOOP AND ZIPPERS HAVE NO TEARS, RIPS OR SNAGS AND LOCK IS SECURED" ON PAGE 22 INCLUDES A MONTHLY MAINTENANCE CHECKLIST, ONE CHECK IS: "EACH ZIPPER ON THE CANOPY IS FUNCTIONAL AND SEAMS OF ZIPPERS ARE INTACT" PAGE 22 OF THE USER MANUAL, MAINTENANCE CHECKLIST, DESCRIBES TO DISCONTINUE USE OF THE BED IF ANYTHING IS DAMAGED OR MISSING. ADDITIONAL INVESTIGATION IS NEEDED, AND SENSORY MEDICAL'S ROOT CAUSE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    PER PARENT, HER DAUGHTER BROKE THE CANOPY DOOR ZIPPERS AND ESCAPED THE BED, THEN CLIMBED UP ON THE TOP OF THE BED, OPENED THE TOP OF A SECOND STORY WINDOW AND JUMPED OUT. THE COMPLAINANT STATED THIS EVENT OCCURRED ON OCTOBER 13, 2025. PER SCREENSHOTS PROVIDED BY THE COMPLAINANT OF WHAT APPEARS TO BE PART OF THE MEDICAL REPORT, HER DAUGHTER'S INJURIES INCLUDED THE LOSS OF 1 ADULT INCISOR (LISTED AS TOOTH #9), A 3 CM LINEAR DEEP CHIN LACERATION, A 2 CM PARTIAL THICKNESS MUCOSAL LACERATION OF THE LOWER LIP, AND THREE 0.5 CM SIMPLE LACERATIONS OF THE EXTRAORAL CHIN. THE COMPLAINANT STATED HER DAUGHTER ALSO BROKE HER JAW IN 3 DIFFERENT PLACES AND BROKE THREE TEETH, WHICH COULD NOT BE VERIFIED BY MEDICAL RECORD. A PICTURE SHOWS THE CHILD'S HEALED INJURIES WITH A MISSING TOP FRONT LEFT INCISOR, AND TWO SCARS ON THE CHILD'S CHIN. PICTURES PROVIDED SHOW THE STITCHED LACERATIONS TO HER CHIN AND LOWER LIP, THE UNSTITCHED CHIN LACERATION, AND THE MISSING TOOTH. A PICTURE SHOWS THE CHILD WITH THE CLINICAL TEAM WORKING ON HER INJURIES. ANOTHER PICTURE SHOWS THE CHILD WITH A BANDAGE ON HER CHIN. PER PARENT, HER DAUGHTER HAS AUTISM AND IS NONVERBAL. THE COMPLAINANT SAYS THEY ARE STILL SEEKING DENTAL CARE FOR HER DAUGHTER. THE COMPLAINANT STATED THE BED HAD BEEN WORKING WITH NO ISSUE UNTIL THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2381606 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC. 241010M10 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| O