MAUDE Adverse Event Report: RANIR LLC REST ASSURED GEN II; MOUTHGUARD, OVER-THE-COUNTER

Model Number REST ASSURED GEN. II 2PK

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 12/30/2020

Event Type  malfunction  

Event Description

Consumer stated that the guard separated.Product returned and the guard was separated in two pieces.Old design of dental guard.

• Brand Name: REST ASSURED GEN II
• 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: 11250459
• MDR Text Key: 230329417
• Report Number: 1825660-2021-00900
• Device Sequence Number: 1
• Product Code: OBR
• UDI-Device Identifier: 5042863352
• UDI-Public: 5042863352
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: REST ASSURED GEN. II 2PK
• Device Lot Number: 388991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Distributor Facility Aware Date: 12/30/2020
• Date Manufacturer Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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