FDA.reportPublic FDA data

MAUDE MDR 8034937

MDR report key
8034937
Report number
1825660-2018-00445
Event key
0
Event type
3
Date of event
2018-10-23
Date received
2018-11-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
REBEKAH STENSKE
Address
4701 EAST PARIS AVE. SE GRAND RAPIDS MI 49512 US
Phone
616-616-6166
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KROGER MTH GD RST ASRD W/TRAY 2CTMOUTHGUARD, OVER-THE-COUNTERRANIR LLCOBRMTH GD RST ASRD W/TRAY 2CT CD* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-020

Event Narratives#

D

Patient 1

CONSUMER STATED SHE PURCHASED NIGHT GUARD IN ORDER TO PROTECT HER INVISALIGN. AFTER USING YOUR PRODUCT, SHE CLAIMS THAT SHE DEVELOPED A THROAT INFECTION. SHE SAID SHE HASN'T HAD ANY ISSUES WITH ANY OTHER PRODUCTS EXCEPT FOR YOURS. HER DOCTOR GAVE HER AN ANTIBIOTIC AND SHE THOUGHT THAT MAYBE SHE COULD TRY IT AGAIN AFTER BEING ON ANTIBIOTICS FOR 10 DAYS. SHE TRIED IT AGAIN ONE NIGHT AND IT IRRITATED MY THROAT AND SHE HAD TO TAKE IT OUT IN THE MIDDLE OF THE NIGHT. SHE SAID "I'M A PRETTY HEALTHY PERSON, I CAN'T IMAGINE I JUST DEVELOP A THROAT INFECTION FOR NO REASON. I THINK IT'S YOUR PRODUCT." UPDATE (B)(6) 2018 HER DOCTOR SAID SHE DIDN'T HAVE A STAPH INFECTION JUST AN "ALLERGIC REACTION". EVEN THOUGH SHE HAD THIS REACTION, SHE HAS STILL BEEN WEARING THE GUARD BECAUSE SHE WEARS THE INVISALIGN AND DOESN'T WANT TO GRIND THAT DOWN. SHE PURCHASED THIS THE END OF (B)(6), AND HAS BEEN USING IT FOR A FEW WEEKS.