FDA.reportPublic FDA data

MAUDE MDR 4745550

MDR report key
4745550
Report number
MW5042454
Event key
0
Event type
3
Date received
2015-04-28
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
305
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0NEUROFEEDBACK CYGNET EEGEEGHCCC510137

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-04-2801. H; 2. L; 3. R; 4. S

Event Narratives#

D

Patient 1

VERY COMPLICATED DEVICE SOLD WITHOUT PRESCRIPTION; PRACTITIONER WAS NOT MD. I BECAME WORSE AND GOT IN A CAR ACCIDENT. ADVERSE EFFECTS: SEVER TICKS, IMPULSIVITY, RAGE, PERSONALITY CHANGE, CONFUSION, MEMORY PROBLEMS, INABILITY TO OBSERVE INFO, POOR AND VERY SLUGGISH TIME REACTION.