FDA.reportPublic FDA data

MAUDE MDR 3590155

MDR report key
3590155
Report number
1525712-2014-00452
Event key
0
Event type
3
Date received
2014-01-23
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
PATRICIA MEDINA
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
1WHEELCHAIR ACCESSORY890.3910UNKNOWNINET93HE_37918R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-01-2301. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE FOOTPLATE ON A FRONT RIGGINGS WERE CRACKED.