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

Model Number REST ASSURED EXTRA COMFORT UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Laceration(s) (1946); Pain (1994)

Event Date 08/29/2017

Event Type  Injury  

Event Description

Consumer stated the dental protector created cuts along my gums and she had to go to her dentist to remove food that was caught in those cuts and was in pain for several days.

• 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: 6893708
• MDR Text Key: 87352012
• Report Number: 1825660-2017-00157
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• 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: Patient
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: REST ASSURED EXTRA COMFORT UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/29/2017
• Date Manufacturer Received: 08/29/2017
• 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