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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSORY MEDICAL INC CUBBY BED ENCLOSED CANOPY BED; PATIENT BED WITH CANOPY/RESTRAINTS
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SENSORY MEDICAL INC CUBBY BED ENCLOSED CANOPY BED; PATIENT BED WITH CANOPY/RESTRAINTS Back to Search Results
Model Number CUB2
Device Problems Break (1069); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The allegations described herein were noted during the manufacturer's retrospective complaint handling process improvement efforts.
 
Event Description
During the manufacturer's retrospective complaint handling process improvement efforts, the following allegation was noted: bed slats starting to break.
 
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Brand Name
CUBBY BED ENCLOSED CANOPY BED
Type of Device
PATIENT BED WITH CANOPY/RESTRAINTS
Manufacturer (Section D)
SENSORY MEDICAL INC
1514 blake st.
ste., 200
denver 80202
Manufacturer (Section G)
SENSORY MEDICAL INC
1514 blake st.
ste., 200
denver CO 80202
Manufacturer Contact
caleb polley
1514 blake st.
ste., 200
denver, CO 80202
8559642664
MDR Report Key16040597
MDR Text Key308447947
Report Number3020824629-2022-00005
Device Sequence Number1
Product Code OYS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
510(K)-EXMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCUB2
Device Catalogue NumberCUB2
Device Lot NumberNONE
Was Device Available for Evaluation? No
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNO 21 USC 360I(F) ACTION
Patient Sequence Number1
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