MAUDE Adverse Event Report: RANIR LLC LIFE BRAND; MOUTHGUARD, OVER-THE-COUNTER

Model Number REST ASSURED WITH TRAY

Device Problem Fitting Problem (2183)

Patient Problem Irritation (1941)

Event Date 01/04/2019

Event Type  malfunction  

Event Description

Consumer stated he just got a nite protector a few weeks ago and he started wearing it but the first time it didn't fit too well, so he re-molded it, but it seems like it's falling apart in one place and it's irritating his mouth.

• Brand Name: LIFE BRAND
• 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: 8287622
• MDR Text Key: 134579134
• Report Number: 1825660-2019-00485
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• 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
• Device Lot Number: 220937A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/04/2019
• Date Manufacturer Received: 01/04/2019
• 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