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

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

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Swelling (2091); Burning Sensation (2146); Reaction (2414)

Event Date 06/29/2018

Event Type  Injury  

Event Description

Consumer claimed the product caused her lip to get red,burn, and swelling.Reporter/patient will seek medical attention.Update: she molded it just fine, and liked it because it was helping.After using it for a few weeks she was fine then all of a sudden one day she woke up, removed it and the inside of her lips were swollen, red (where her lips touched the guard).She stopped using the guard for a few weeks, but her dentist said to try again.She tried it, woke up two hours later and it was really swollen and more sore.Still sore 4 days later, still swollen and red, however not burning like it was initially and her lips feel dry.She has not spoken to a doctor, took some (b)(6) did not notice a difference with that.

• Brand Name: EQUATE MTH GD RST ASRD W/TRAY
• 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 ; 4701 east paris ave. se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 7710905
• MDR Text Key: 114728749
• Report Number: 1825660-2018-00373
• Device Sequence Number: 1
• Product Code: OBR
• 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: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• 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: 223114A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Distributor Facility Aware Date: 06/29/2018
• Date Manufacturer Received: 06/29/2018
• 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