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

Model Number REST ASSURED NITE PROTECT

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 11/16/2016

Event Type  No Answer Provided  

Event Description

I have purchased numerous bite guards thru the years.Sometimes i have trouble with results while following the instructions.Why did the soft and (heet) hard part separate.Has happened before just never sought replacement.

• Brand Name: REST ASSURED NITE PROTECTOR
• 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: brenda mumbower ; 4701 east paris ave se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 6171535
• MDR Text Key: 62673733
• Report Number: 1825660-2016-00049
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091792
• 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: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Device Unattended
• Device Model Number: REST ASSURED NITE PROTECT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/16/2016
• Date Manufacturer Received: 11/16/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1