MAUDE Adverse Event Report: RANIR LLC PLACKERS MTH GD GNM 10; MOUTHGUARD, OVER-THE-COUNTER

Model Number MTH GD GNM 10 CA

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/31/2020

Event Type  malfunction  

Event Description

Consumer stated: my mouth broke out after using the grind no more disposable night guard, an allergic reaction.I see that they are bpa and latex free, but what material are they made of? nitrile? i'm asking do i know what materials to stay away from due to the reaction i had.Product was not returned.

• Brand Name: PLACKERS MTH GD GNM 10
• 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 ; 6166988880
• MDR Report Key: 10891117
• MDR Text Key: 221016749
• Report Number: 1825660-2020-00850
• Device Sequence Number: 1
• Product Code: OBR
• UDI-Device Identifier: 00651080906517
• UDI-Public: 651080906517
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD GNM 10 CA
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/02/2020
• Date Manufacturer Received: 11/02/2020
• 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