FDA.reportPublic FDA data

MAUDE MDR 6995803

MDR report key
6995803
Report number
MW5073087
Event key
0
Event type
3
Date of event
2014-01-31
Date received
2017-11-02
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
1DENTAL BRACESORTHODONTIC BRACKETSORMCOEJFI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-0201. S

Event Narratives#

D

Patient 1

I HAD BRACES, AND IT IS VERY BAD EFFECT TO MY BODY HEALTH AND MENTAL HEALTH. IT DESTROYS MY TEETH THAT MY TEETH AND GUM LOOKS VERY UGLY. IT MADE ME MENTALLY VERY UNSTABLE, AND CAN NOT STUDY, CONCENTRATE, AND LIVE BY MYSELF. I CAN NOT DO WHAT I CAN DO BEFORE LIKE GO TO SCHOOL OR EAT. THE DENTAL BRACES TOTALLY DESTROYED MY HEALTHY LIFE. CAN NOT GO TO SCHOOL OR STUDY. VERY HARD TO COMMUNICATE TO SOMEONE DUE TO DESTRUCTIVE MENTAL HEALTH. DATES OF USE: (B)(6) 2014 - (B)(6) 2015.