FDA.reportPublic FDA data

MAUDE MDR 5815124

MDR report key
5815124
Report number
MW5063596
Event key
0
Event type
3
Date of event
2016-05-17
Date received
2016-07-19
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
1ARESARESMNR* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-1901. O

Event Narratives#

D

Patient 1

I WAS PRESCRIBED A HOME SLEEP STUDY BY MY PHYSICIAN. I WAS SENT TO AN ARES DEVICE TO WEAR TO COLLECT THE DATA FROM THE STUDY. THE FOLLOWING MORNING, I WAS LEFT WITH A LARGE RED BLISTERED MARK ON MY FOREHEAD AND SEVERE HEADACHE. THE MARK ON MY FOREHEAD PERSISTED AND I STILL HAVE A LARGE RED SCAR THERE FROM THE DEVICE.