FDA.reportPublic FDA data

MAUDE MDR 5127458

MDR report key
5127458
Report number
1525712-2015-04755
Event key
0
Event type
3
Date received
2015-10-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

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
13 POSITION RECLINER BASIC ROSEWOOD 9153641231CHAIR AND TABLE, MEDICALUNKNOWNKMNUNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-10-050

Event Narratives#

N

Patient 1

A FOLLOW UP WILL BE SENT IF THE PRODUCT OR ADDITIONAL INFORMATION IS OBTAINED.

D

Patient 1

BROKEN FRAME ON THE SIDE OF A RECLINE CHAIR.