MAUDE Adverse Event Report: RANIR LLC EQUATE; MOUTHGUARD, OVER-THE-COUNTER

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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Therapeutic Effects, Unexpected (2099); Stenosis (2263); Reaction (2414)

Event Date 12/03/2018

Event Type  malfunction  

Event Description

Reporter/patient stated that the eq ex comft ngt gd made her throat tighten down and her eyes started to water update: she wore the guard the first night and everything was ok.On the second night her eyes were watering and she started cough and her throat started to close up.It took about two days for her throat to return to normal.She had to use her inhaler multiple times.She believes she was having a reaction to elvax because she had a reaction to dentex a few months earlier.She has a very tight neck (stenosis), had surgery a few years ago and when her neck is bothering her she tends to grind more at night.She used to have a guard from the dentist but no longer uses that due to grinding it down so badly.

• Brand Name: EQUATE
• 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: 8189214
• MDR Text Key: 131375463
• Report Number: 1825660-2018-00467
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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: 239540A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/03/2018
• Date Manufacturer Received: 12/03/2018
• 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