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

Model Number MTH GD GNM 10

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 02/13/2021

Event Type  malfunction  

Event Description

Consumer stated: i¿ve been using these for about a week.I woke up this morning, and the guard was missing.I checked all around and under the bed.No guard.I¿m guessing i swallowed it while i was asleep.Consumer didn't respond whether or not he found the guard in his bed.

• 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: 11464159
• MDR Text Key: 244192233
• Report Number: 1825660-2021-00916
• Device Sequence Number: 1
• Product Code: OBR
• UDI-Device Identifier: 00651080651516
• UDI-Public: 651080651516
• Combination Product (y/n): N
• PMA/PMN Number: K094020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• 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 10
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/13/2021
• Date Manufacturer Received: 02/13/2021
• 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