FDA.reportPublic FDA data

MAUDE MDR 2310041

MDR report key
2310041
Report number
1027229-2011-00004
Event key
0
Event type
3
Date of event
2011-10-13
Date received
2011-10-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
5516 S.W. FIRST LN. OCALA FL 34474 US
Phone
800-800-8002
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WINCOELITE CARE CLINERWINCO MFG, LLC.FRJ6950R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-10-2001. O

Event Narratives#

D

Patient 1

(B)(6) NURSING HOME IN (B)(6) CONTACTED WINCO MFG ON (B)(6) 2011 TO REPORT AN INCIDENT WHICH RESULTED IN AN INJURY TO A PATIENT. THE PATIENT WAS SEATED IN A WINCO 6950 ELITE CARE CLINER XL CHAIR. THE STAFF MEMBER LEFT THE PATIENT UNATTENDED, AND, UPON RETURNING TO THE ROOM, FOUND THE PATIENT LAYING FACE DOWN ON THE FLOOR. THE PATIENT SUSTAINED AN INJURY TO HER FOREHEAD AND TO HER LIP. THE PATIENT CANNOT COMMUNICATE AND WAS UNABLE TO EXPLAIN WHAT HAD HAPPENED.

N

Patient 1

(B)(4) OF WINCO MFG HAD AN ADDITIONAL CONVERSATION WITH A REPRESENTATIVE OF (B)(6) ON (B)(6) 2011. (B)(6) STATED THAT SHE DID NOT KNOW THAT THE MODEL OF CHAIR IN USE WAS NOT DESIGNED TO LOCK. (B)(6) ADVISED THAT THE FACILITY SHOULD PURCHASE A LONG TERM CARE CHAIR THAT HAS A LOCKING FEATURE. THE FACILITY DID NOT REPORT ANY DEFECT WITH THE CHAIR. THE FACILITY ALSO STATED THAT THE PATIENT INVOLVED WAS KNOWN TO 'SCOOT' WHILE IN THE CHAIR.