FDA.reportPublic FDA data

MAUDE MDR 5797975

MDR report key
5797975
Report number
MW5063436
Event key
0
Event type
3
Date received
2016-07-12
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
1NARVALNARVALRESMEDLQZ* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-1201. R; 2. S

Event Narratives#

D

Patient 1

THE NARVAL SLEEP APNEA DEVICE OWNED BY (B)(4), ISN'T FIRM ENOUGH TO KEEP IT FROM PUTTING PRESSURE ON YOUR TEETH LIKE A ORTHODONTIC RETAINER. MY TEETH HAVE SHIFTED AND I CAN NO LONGER CHEW OR CLOSE MY TEETH. (B)(4) HAS NOT OFFERED ME ANY SOLUTIONS, DESPITE HAVING A THREE YEAR WARRANTY. I HAVE NO IDEA HOW I'M GOING TO GET MY BITE, PROBABLY WILL NEED TO SEE AN ORTHODONTIST.