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

Model Number MTH GD GNM 10CT

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2020

Event Type  malfunction  

Event Description

Consumer stated she has been using plackers night guards for at least 5 months.She said she swallowed it.When she woke up, it wasn¿t in her mouth any more.It¿s never happened before.She has no discomfort or feeling that it is in her throat.Informed consumer to let us know if the guard was found later in her 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: 11101436
• MDR Text Key: 226331715
• Report Number: 1825660-2020-00880
• 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: Other
• Type of Report: Initial
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• 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 10CT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/07/2020
• Date Manufacturer Received: 12/07/2020
• 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