MAUDE Adverse Event Report: RANIR LLC UP&UP MTH GD RST ASRD W/TRAY 2CT CD; MOUTHGUARD, OVER-THE-COUNTER

Model Number MTH GD RST ASRD W/TRAY 2CT CD

Device Problem Break (1069)

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

Event Date 10/16/2018

Event Type  malfunction  

Event Description

Consumer stated the first one fell apart within a week after molding.Did not seem to have any issues with the molding process.No contact information provided.

• Brand Name: UP&UP MTH GD RST ASRD W/TRAY 2CT CD
• 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: 8120884
• MDR Text Key: 129344676
• Report Number: 1825660-2018-00455
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• 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: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD RST ASRD W/TRAY 2CT CD
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/13/2018
• Date Manufacturer Received: 11/13/2018
• 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