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

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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Rash (2033); Swelling (2091); Reaction (2414); Sensitivity of Teeth (2427)

Event Date 07/06/2018

Event Type  malfunction  

Event Description

Consumer stated that the eq ex comft ngt gd caused her to get fine bumps on her lips and experience some irration.No medical attention was sought as yet.Update: 7.11.2018 after using it for a couple nights, the left side of her lip had started to break out and her teeth were sore.When she woke up the next morning her lip was swollen and broken out.Specifically bottom left lip.It is starting to go away and scab over, teeth are no longer sore since she stopped use.

• Brand Name: EQUATE MTH GD RST ASRD W/TRAY 2CT
• 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: 7744777
• MDR Text Key: 116058455
• Report Number: 1825660-2018-00377
• 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: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD RST ASRD W/TRAY 2CT CD
• Device Lot Number: 222388A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/06/2018
• Date Manufacturer Received: 07/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 0