FDA.reportPublic FDA data

MAUDE MDR 4697825

MDR report key
4697825
Report number
1525712-2015-02525
Event key
0
Event type
3
Date received
2015-04-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
403
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
KEVIN GUYTON
Address
ONE INVACARE WAY ELYRIA OH 44035 US
Phone
800-800-8003
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1T93ACFOOTREST, WHEELCHAIRUNKNOWNIMMT93HE_PTO_37918R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-04-1601. O

Event Narratives#

D

Patient 1

THE PROVIDER STATES THE WELD ON THE FRONT RIGGING IS BROKEN. HE STATES THE RELEASE LEVER BROKE AT THE WELD. NO INJURIES NOTED. HE STATES THE FRONT RIGGING DIDN'T GO WITH A SPECIFIC CHAIR.