EQUATE MTH GD RST ASRD W/TRAY 2CT CD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-20 for EQUATE MTH GD RST ASRD W/TRAY 2CT CD manufactured by Ranir Llc.

Event Text Entries

[184424333] Consumer stated she used the extra comfort night protector (bruxism guard) and she broke out in her mouth. She described the outside as red and visible blisters and the rash on the inside of the mouth was different. Customer said the only change to her routine was the mouth guard and this has never happened to her before while using a mouth guard. Customer would also like to be compensated for the doctors visits because she had to spend money out of her co pay to figure out what was wrong with no success with figuring out. This has been an ongoing issue for 4 months. She has been to a dermatologist 3 times, paid (b)(6) out of pocket. Also been to an ent twice, has paid multiple co pays and saw her primary dr. She did not notice anything at first when she began using the guard, but after wearing the guard for about 3-4 weeks, she really noticed what was happening in her mouth. She had been under a lot of stress and was and having anxiety attacks. She felt like she woke up one day and went from having oral tenderness to having swollen lips (like someone who got injections), swollen and red lips almost translucent, her lip pigment was hyper pigmented. On the inside of her mouth there are a number of different areas along her gum line that are swollen, less pink than normal, like they lost pigment of color. She called them water pockets consumer was very concerned but none of the drs could confirm what the issue is. Dr. Recommended not wearing the guard. Consumer said the guard changed color to a sort of yellow color. After not wearing it for a while she was grinding her teeth so badly she popped it in her mouth and all her symptoms came back again the very next day. She has a professional guard that needed to be tweaked and that's is why she went to an over the counter one. Dermatologist recommended a compounding agent to help with inflammation some sort of statin hydrocortisone, a type of steroid, compounded liquid agent. Also using "curoxen" an organic mouth treatment for mouth sores that she picked up from a local health food store. Now 4 months later her upper teeth feel better but her lower teeth/gums are at about a level 4 of pain. It bothers her to eat/drink and talk. Received guard back in the mail on 3/11.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1825660-2020-00737
MDR Report Key9862861
Report SourceCONSUMER
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2020-02-21
Date Facility Aware2020-02-21
Date Mfgr Received2020-02-21
Date Added to Maude2020-03-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactREBEKAH STENSKE
Manufacturer Phone6166988880
Manufacturer G1RANIR LLC
Manufacturer Street4701 EAST PARIS AVE. SE
Manufacturer CityGRAND RAPIDS MI 495125353
Manufacturer CountryUS
Manufacturer Postal Code495125353
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEQUATE MTH GD RST ASRD W/TRAY 2CT CD
Generic NameMOUTHGUARD, OVER-THE-COUNTER
Product CodeOBR
Date Received2020-03-20
Returned To Mfg2020-03-11
Model NumberMTH GD RST ASRD W/TRAY 2CT CD
Lot Number281225A
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerRANIR LLC
Manufacturer Address4701 EAST PARIS AVE. SE GRAND RAPIDS MI 495125353 US 495125353


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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