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 Fitting Problem (2183)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 04/28/2018

Event Type  malfunction  

Manufacturer Narrative

Device was not returned.

Event Description

Consumer stated she loves it, but "these are so uncomfortable and fitting it with a full gold cap.I think i loosened it.I woke with such jaw pain, up to my ear.I threw it in the case in a drawer.".

• 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: 7544419
• MDR Text Key: 109626924
• Report Number: 1825660-2018-00332
• 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
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• 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: 185571 B
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/28/2018
• Date Manufacturer Received: 04/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1