FDA.reportPublic FDA data

MAUDE MDR 7052417

MDR report key
7052417
Report number
MW5073521
Event key
0
Event type
3
Date of event
2017-11-15
Date received
2017-11-22
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#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1L300 GOSTIMULATOR, NEUROMUSCULAR, EXTERNALBIONESSGZII Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-2201. R

Event Narratives#

D

Patient 1

BRACE BURNED SKIN. CAUSING PAIN AND DIFFICULTY WALKING WITH ALREADY HAVING DIFFICULTIES HENCE THE NEED FOR THE BRACE.