MAUDE Adverse Event Report: RANIR LLC UNKNOWN BRAND, REST ASSURED WITH FITTING TRAY; MOUTHGUARD, OVER-THE-COUNTER

Model Number REST ASSURED WITH TRAY UNKNOWN

Device Problem Material Disintegration (1177)

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

Event Date 03/10/2020

Event Type  malfunction  

Event Description

Consumer stated the bruxism guard was coming apart/disintegrating.He had it about a month.Would like a replacement guard.Product was not returned.

• Brand Name: UNKNOWN BRAND, REST ASSURED WITH FITTING 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 ; 6166988880
• MDR Report Key: 9940438
• MDR Text Key: 190515130
• Report Number: 1825660-2020-00745
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/10/2020
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1