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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEMSCHOFF PALISADES SWIVEL STOOL; STOOL, SWIVEL

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NEMSCHOFF PALISADES SWIVEL STOOL; STOOL, SWIVEL Back to Search Results
Model Number 867-28
Device Problems Collapse (1099); Detachment Of Device Component (1104); Fitting Problem (2183)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 10/12/2016
Event Type  Injury  
Event Description
Nurse was sitting on the stool at the nurses station doing documentation/charting.The stool collapsed/fell apart while she was sitting on it.She fell onto the floor and fractured her tail bone.The post and seat detached from the base.The bolt that attaches the post to the base is very short.It looks like it is too short to adequately secure the post to the base.Manufacturer was notified and sent a technician to inspect and repair the stool.He replaced the original bolt with a longer bolt.The nurse weighs (b)(6).The stool has a weight capacity of 350 lbs (per manufacturer's specs).
 
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Brand Name
PALISADES SWIVEL STOOL
Type of Device
STOOL, SWIVEL
Manufacturer (Section D)
NEMSCHOFF
909 north 8th street
sheboygan WI 53081
MDR Report Key6061737
MDR Text Key58557551
Report Number6061737
Device Sequence Number1
Product Code INM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number867-28
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/25/2016
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer10/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Outcome(s) Other;
Patient Weight85
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