MAUDE Adverse Event Report: RANIR LLC KROGER 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 Unspecified Infection (1930); Irritation (1941)

Event Date 10/23/2018

Event Type  malfunction  

Event Description

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.

• Brand Name: KROGER 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: 8034937
• MDR Text Key: 126224532
• Report Number: 1825660-2018-00445
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• 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: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• 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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/23/2018
• Date Manufacturer Received: 10/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1