MAUDE Adverse Event Report: RANIR LLC PLACKERS MTH GD GNM; MOUTHGUARD, OVER-THE-COUNTER

Model Number MTH GD GNM 14

Device Problem Malposition of Device (2616)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2020

Event Type  malfunction  

Event Description

Consumer posted on facebook: "(b)(6) has tmj so she wears these night guards to keep her from grinding her teeth.Monday night sometime she swallowed one in her sleep.We figured it would just have to work its way down, and out poop.This morning she said she felt like it was in the same spot in her throat.So we went to the er and had x-ray.They couldn't see it because it is plastic.So we saw the gastroenterologist, and they want us to be at the hospital at 7am tomorrow morning.They are going to put her to sleep, go down her throat with a camera, and try to find it and pull it out.(b)(6) is crapping tacks over getting an iv.So if you would throw a little prayer up for her.Help her not be afraid, and that they can get it out without having to do surgery." reached out to consumer, but did not hear a response back.

• Brand Name: PLACKERS MTH GD GNM
• 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 hamilton ; 6166988880
• MDR Report Key: 11023537
• MDR Text Key: 223805254
• Report Number: 1825660-2020-00866
• Device Sequence Number: 1
• Product Code: OBR
• UDI-Device Identifier: 00651080637060
• UDI-Public: 651080637060
• Combination Product (y/n): N
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD GNM 14
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/17/2020
• Date Manufacturer Received: 11/17/2020
• 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