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

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

Device Problem Material Fragmentation (1261)

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

Event Date 09/19/2018

Event Type  malfunction  

Event Description

Consumer purchased night guard 2ct - up&up.Consumer said pieces of it is coming off and if swallowed guest would like to know if the materials this is made out of can be harmful or not.Store clerk resolved with consumer.

• Brand Name: UP&UP MTH GD RST ASRD W/TRAY 2CT
• 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: 8019272
• MDR Text Key: 125614607
• Report Number: 1825660-2018-00440
• 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: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• 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: 10/16/2018
• Date Manufacturer Received: 10/16/2018
• 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