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

Model Number MTH GD GNM 10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Choking (2464)

Event Date 12/18/2017

Event Type  Injury  

Event Description

Consumer stated she nearly choked on it the first night."half way through the night the one i used was lodged in the back of my mouth.I woke up because i felt as that i was choking!!".

• Brand Name: PLACKERS
• 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: 7193192
• MDR Text Key: 97312101
• Report Number: 1825660-2017-00227
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K091175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD GNM 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/18/2017
• Date Manufacturer Received: 12/18/2017
• 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