MAUDE MDR 703857

MDR report key
703857
Report number
1834066-2006-00001
Event key
0
Event type
3
Date of event
2006-01-17
Date received
2006-04-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
RON CLINES
Address
ONE INVACARE WAY ELYRIA OH 44036 US
Phone
440-440-4403
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CHAMPION MFG880.6140CHAMPION MFG. INC.FIA54 SERIES54 SERIESNANRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-04-2401. R

Event Narratives#

D

Patient 1

THE LETTER FROM AN ATTORNEY ALLEGES THE CONSUMER'S LEGS FLIPPED OFF THE CHAIR AND HIT A BOLT, CAUSING A HEMATOMA THAT REQUIRED SURGERY.