BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUBBY BEDS

    MDR report key: 24959906 · Received April 22, 2026

    Report

    Report Number
    3016541541-2026-00028
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 21, 2026
    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 04/01/2026, 04/03/2026, 4/07/2026, AND 04/10/2026 [EMAILS] AND 04/13/2026 AND 04/14/2026 [PHONE CALLS] TO OBTAIN DETAILS RELEVANT TO THE INVESTIGATION. THE PARENT DID NOT RESPOND TO THE REQUESTS BY SENSORY MEDICAL. SENSORY MEDICAL ADVISED THE PARENT TO DISCONTINUE USE OF THE BED UNTIL THE ISSUES COULD BE RESOLVED. 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 CUBBY BED USER MANUAL CONTAINS A WARNING FOR ENTRAPMENT HAZARD. "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 3 OF THE CUBBY BED USER MANUAL CONTAINS A WARNING FOR "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." PAGE 3 OF THE CUBBY BED USER MANUAL CONTAINS A WARNING FOR "IF ANY DAMAGE IS PRESENT, IMMEDIATELY DISCONTINUE USE AND CONTACT CUBBY FOR REPAIR OR REPLACEMENT." PAGE 5 CONTAINS A PARTS LIST, WHICH INCLUDES THE SAFETY SHEETS AND LOCKS. 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. ON PAGE 15 "WHAT HAPPENS IF MY CUBBY RIPS OR I NOTICE OTHER DAMAGE? PLEASE CONTACT US RIGHT AWAY. ONLY USE YOUR CUBBY BED WHEN IT IS ASSEMBLED CORRECTLY AND IS IN SAFE WORKING CONDITION." PAGE 15 ASSEMBLY + CARE FAQ'S INCLUDES DESCRIPTION AND USE OF THE LOCKS ON THE SAFETY SHEETS AND THE TECHNOLOGY HUB ZIPPERS. 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 DISCONTINUING 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, THEIR SON BROKE THE SAFETY SHEET ZIPPER TEETH, PREVENTING THE SHEET FROM BEING INSTALLED. PER PARENT, THEY CONTINUED USE OF THE DAMAGED SAFETY SHEET WITHOUT THE SHEET BEING FULLY ASSEMBLED, THEN THE CHILD BECAME ENTRAPPED BETWEEN THE MATTRESS AND THE FRAME. PER PARENT, THE ENTRAPMENT LED TO THE DISLOCATION OF THE CHILD'S KNEE, WHICH RESULTED IN A VISIT TO THE EMERGENCY ROOM. PER PARENT, AT THE ER, AN HCP FIXED THE CHILD'S KNEE AND SENT THEM HOME. PER PARENT, THE CHILD IS DOING "OKAY" SINCE THE VISIT. PER PARENT, A SIMILAR EVENT HAS OCCURRED 3 TIMES, WITH TWO REQUIRING TRIPS TO THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020659 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL INC. 240912M12 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male