BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUBBY BEDS

    MDR report key: 22799877 · Received August 13, 2025

    Report

    Report Number
    3016541541-2025-00059
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    June 23, 2025
    Report Date
    August 13, 2025
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    OYS
    UDI-DI
    00860007550249
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL HAS SENT A REPLACEMENT CANOPY TO THE COMPLAINANT. SENSORY MEDICAL REQUESTED A RETURN OF THE CANOPY IN USE DURING THE EVENT AND REQUESTED COPIES OF THE MEDICAL RECORDS OR DISCHARGE PAPERS. 240329M10 IS THE LOT OF THE CANOPY USED DURING THE EVENT. 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 ENTRAPMENT 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 5 CONTAINS A PARTS LIST, WHICH INCLUDES THE LOCKS 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 15 ASSEMBLY + CARE FAQ'S INCLUDES DESCRIPTION AND USE OF THE LOCKS ON THE SAFETY SHEETS AND THE TECHNOLOGY HUB ZIPPERS. WARNINGS ARE ADDRESSED IN PACK80020 V1.0 CUBBY BED USER MANUAL. 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". PAGE 22 OF THE USER MANUAL, MAINTENANCE CHECKLIST, DESCRIBES DISCONTINUING USE OF THE BED IF ANYTHING IS DAMAGED OR MISSING. SENSORY MEDICAL'S ROOT CAUSE INVESTIGATION IS ONGOING, AND THE COMPANY WILL SUPPLEMENT THIS REPORT AS NECESSARY.

    Additional Manufacturer Narrative · 0

    CORRECTION: SENSORY MEDICAL HAS SENT A REPLACEMENT CANOPY TO THE COMPLAINANT. 240329M10 IS THE LOT OF THE CANOPY USED DURING THE EVENT. 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 ENTRAPMENT 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 5 CONTAINS A PARTS LIST, WHICH INCLUDES THE LOCKS 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 15 ASSEMBLY + CARE FAQ'S INCLUDES DESCRIPTION AND USE OF THE LOCKS ON THE SAFETY SHEETS AND THE TECHNOLOGY HUB ZIPPERS. WARNINGS ARE ADDRESSED IN PACK80020 V1.0 CUBBY BED USER MANUAL. 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" 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. THE COMPANY REQUESTED A RETURN OF THE CANOPY USE DURING THE EVENT, AS WELL AS COPIES OF THE MEDICAL RECORDS AND/OR DISCHARGE PAPERS. THE COMPANY WILL SUPPLEMENT THIS REPORT AS NECESSARY.

    Description of Event or Problem · 0

    PER PARENT, HER SON ESCAPED OUT OF THE BED THROUGH THE SAFETY SHEET ZIPPER AND BECAME STUCK BETWEEN THE CANOPY FRAME AND THE MATTRESS. PER PARENT, SHE TOOK HIM TO THE HOSPITAL AND HE WAS DIAGNOSED WITH A FRACTURED COLLARBONE AND A DISLOCATED (NURSEMAID'S) ELBOW. SHE SAID HE WAS KEPT AT THE HOSPITAL FOR 5 DAYS AND WAS OBSERVED FOR CONCUSSION SINCE THERE WERE NO WITNESSES TO THE EVENT AND HER SON IS NON-VERBAL, BUT NO CONCUSSION SYMPTOMS PRESENTED. PER PARENT, HER SON HAD PREVIOUSLY ESCAPED THE BED, BUT USING THE LOCKS HAD FIXED THE PROBLEM, SO WHEN HE'D ESCAPED A SECOND TIME, THEY REPLACED THE LOCKS, DISCONTINUED USE OF THE SHEET, AND INSPECTED THE OTHER SHEETS. PER PARENT, AFTER THE EVENT, SHE AND HER HUSBAND DISCOVERED SEVERAL ZIPPER TEETH MISSING ON THE CANOPY SIDE SAFETY SHEET ZIPPER CHAIN. A PICTURE THAT IS SLIGHTLY BLURRY SHOWS A GAP ON THE SAFETY SHEET ZIPPER CHAIN ON THE CANOPY SIDE THAT APPEARS TO BE SEVERAL MISSING TEETH.

    Description of Event or Problem · 0

    CORRECTION: PER PARENT, HER SON ESCAPED OUT OF THE BED THROUGH THE SAFETY SHEET ZIPPER AND BECAME STUCK BETWEEN THE CANOPY FRAME AND THE MATTRESS. PER PARENT, SHE TOOK HIM TO THE HOSPITAL AND HE WAS DIAGNOSED WITH A FRACTURED COLLARBONE AND A DISLOCATED (NURSEMAID'S) ELBOW. SHE SAID HE WAS KEPT AT THE HOSPITAL FOR 5 DAYS AND WAS OBSERVED FOR CONCUSSION SINCE THERE WERE NO WITNESSES TO THE EVENT AND HER SON IS NON-VERBAL, BUT NO CONCUSSION SYMPTOMS PRESENTED. PER PARENT, HER SON HAD PREVIOUSLY UNZIPPED THE SAFETY SHEET, BUT USING THE LOCKS HAD FIXED THE PROBLEM, SO 2 MONTHS LATER WHEN HE ESCAPED, THEY REPLACED THE LOCKS WITH NON-CUBBY LOCKS, DISCONTINUED USE OF THE SHEET, AND INSPECTED THE OTHER SHEETS BEFORE USING THEM PRIOR TO THE EVENT DESCRIBE IN THE PARAGRAPH ABOVE. PER PARENT, AFTER THE EVENT, SHE AND HER HUSBAND DISCOVERED SEVERAL ZIPPER TEETH MISSING ON THE CANOPY SIDE SAFETY SHEET ZIPPER CHAIN. A PICTURE THAT IS SLIGHTLY BLURRY SHOWS A GAP ON THE SAFETY SHEET ZIPPER CHAIN ON THE CANOPY SIDE THAT APPEARS TO BE SEVERAL MISSING TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764248 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC. 240329M10 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R