MAUDE Adverse Event Report: RANIR LLC EQUATE MTH GD RST ASRD W/TRAY 2CT CD; MOUTHGUARD, OVER-THE-COUNTER

Model Number MTH GD RST ASRD W/TRAY 2CT CD

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Rash (2033); Skin Discoloration (2074); Swelling (2091); Therapeutic Response, Decreased (2271); Anxiety (2328); Discomfort (2330)

Event Date 02/21/2020

Event Type  Injury  

Event Description

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.

• Brand Name: EQUATE MTH GD RST ASRD W/TRAY 2CT CD
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer Contact: rebekah stenske ; 6166988880
• MDR Report Key: 9862861
• MDR Text Key: 184424333
• Report Number: 1825660-2020-00737
• Device Sequence Number: 1
• Product Code: OBR
• UDI-Device Identifier: 68113113560
• UDI-Public: 68113113560
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD RST ASRD W/TRAY 2CT CD
• Device Lot Number: 281225A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Distributor Facility Aware Date: 02/21/2020
• Date Manufacturer Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1