MAUDE Adverse Event Report: RANIR LLC LIFE BRAND MTH GD RST ASRD W/TRAY CRTN; MOUTHGUARD, OVER-THE-COUNTER

Model Number MTH GD RST ASRD W/TRAY CRTN

Device Problem Device Slipped (1584)

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

Event Date 02/21/2019

Event Type  malfunction  

Event Description

Consumer explained that she purchased this product two nights ago.She followed the instructions and when she went to sleep that same night, it did not stay on her teeth.She woke up as it went to the back of her throat.She was able to remove it from her throat but she feels that it is a choking hazard.

• Brand Name: LIFE BRAND MTH GD RST ASRD W/TRAY CRTN
• 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: 8426189
• MDR Text Key: 139169982
• Report Number: 1825660-2019-00524
• Device Sequence Number: 0
• Product Code: OBR
• 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: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD RST ASRD W/TRAY CRTN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/21/2019
• Date Manufacturer Received: 02/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1