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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOERNS HEALTHCARE COMFORT EXTENSION; BED WIDTH EXTENSION
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JOERNS HEALTHCARE COMFORT EXTENSION; BED WIDTH EXTENSION Back to Search Results
Model Number COMFEXT
Device Problem Material Deformation (2976)
Patient Problem Fall (1848)
Event Date 10/21/2018
Event Type  Injury  
Event Description
It was reported to the manufacturer by the end user, per the end user, "resident rolled on her side against the rail for personal care, rail clips bent gave way.The resident fell to the floor." the resident sustained a fracture to the left femur.(b)(4).Were entered into our system to have the comfort extension returned to joerns for investigation.As of this writing, the comfort extension has not been returned.
 
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Brand Name
COMFORT EXTENSION
Type of Device
BED WIDTH EXTENSION
Manufacturer (Section D)
JOERNS HEALTHCARE
5001 joerns drive
stevens point, WI 54481
Manufacturer (Section G)
JOERNS HEALTHCARE
5001 joerns drive
stevens point, WI 54481
Manufacturer Contact
felicia banks
2100 design road
arlington, TX 76014
8008260270
MDR Report Key8044752
MDR Text Key126353055
Report Number3009402404-2018-00071
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCOMFEXT
Device Catalogue NumberCOMFEXT
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/23/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age69 YR
Patient Weight120
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