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

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

Device Problems Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 01/11/2019

Event Type  malfunction  

Event Description

Reporter/patient stated that he swallowed the eq ex comft ngt gd and wanted to know what to do.Update 1.14.19: consumer woke up and the guard was gone; he checked the bed and it was not in there.He's 100% positive he swallowed and wants to know if there is any toxicity issue he should be aware of.He has noticed some slight stomach aches but isn't sure if that is because he knows he swallowed it or if he's actually having some stomach pains.He said he did pass some of it, not all of it.He's not sure if he bit it into pieces in his sleep or if his stomach acid broke down the guard.He does not think he has passed all of it.He thinks he has been using this for a month/month and a half.He says his family members say he is a heavy grinder, they can hear him at night.He mentioned he has had 2 or 3 root canals due to grinding his teeth.He has used these guards and one from the dentist for the past 15 or so years.He also takes blood pressure medication that tends to dry out his bowel movements.He took an enema (this is regular for him to take) and when he went he noticed most of the guard had come out.He noticed about 4 pieces.He noticed that the guard was clear when it came out, not the opaque color after molding it.He said he does take sleep medication for sleeping.He remembers watching tv, closing his eyes while lying on his back.He thinks it has to do with lying on his back, because he normally sleeps on his side.He thinks that this guard a little smaller than others on the market, he doesn't think the channels are very deep.

• Brand Name: EQUATE MTH GD RST ASRD W/TRAY 2CT CD
• 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: 8295378
• MDR Text Key: 134983336
• Report Number: 1825660-2019-00496
• 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: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• 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: 01/11/2019
• Date Manufacturer Received: 01/11/2019
• 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