MAUDE Adverse Event Report: RANIR LLC REST ASSUREDW/TRAY; MOUTHGUARD, OVER-THE-COUNTER

Model Number REST ASSURED WITH TRAY

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2019

Event Type  malfunction  

Event Description

Consumer stated they "purchased the mouth guard yesterday and followed the instructions unfortunately mine broke." no indication of what part or how the guard broke.Consumer didn't respond after attempts to contact.

• Brand Name: REST ASSUREDW/TRAY
• 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: 8960589
• MDR Text Key: 167644184
• Report Number: 1825660-2019-00608
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: REST ASSURED WITH TRAY
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/08/2019
• Date Manufacturer Received: 08/08/2019
• 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