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

Model Number MTH GD STP GRNDNG 1CT CA

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 08/04/2017

Event Type  Injury  

Manufacturer Narrative

No sample was returned for investigation.Unable to confirm customer complaint.Many other variables may have contributed to an unsatisfactory customer experience which include but are not limited to toothpaste, mouth rinse, fluoride rinse or other personal dental hygiene products.Unable to correlate the use of plackers product to the cause of the allergic reaction.As supported by complaint data, issue is extremely isolated in nature and no other similar incidents / issues have been identified.

Event Description

Consumer has used this product before and she noticed something different this time.She woke up with blisters inside her lip and her chin hurt, had some problems with her jaw.Her chin still hurts, it hurts to touch it.Her jaw doesn't hurt anymore.She normally wears them on the top teeth and now wore this one on the bottom.Consumer claims she doesn't have any allergies.

• 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: 6844501
• MDR Text Key: 84958208
• Report Number: 1825660-2017-00146
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Device Unattended
• Type of Report: Initial
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Device Unattended
• Device Model Number: MTH GD STP GRNDNG 1CT CA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/08/2017
• Date Manufacturer Received: 08/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1