MAUDE Adverse Event Report: RANIR, LLC GRIND NO MORE; NITE GUARD OTC

Model Number GRIND NO MORE

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 12/08/2014

Event Type  Injury  

Event Description

The guard cuts her tongue and the front part digs into her mouth.She was used to wearing the stop grinding guard (other product) and she loves them.She mistakenly bought the grind no more thinking they were the same thing.

Manufacturer Narrative

The guard cuts her tongue and the front part digs into her mouth.I learned that she was used to wearing the stop grinding guard and she loves them.She mistakenly bought the grind no more thinking they were the same thing.

• Brand Name: GRIND NO MORE
• Type of Device: NITE GUARD OTC
• Manufacturer (Section D): RANIR, LLC; 4701 east paris avenue se; grand rapids MI 49512
• Manufacturer (Section G): RANIR, LLC; 4701 east paris avenue se; grand rapids MI 49512
• Manufacturer Contact: elsa baker ; 4701 east paris avenue se; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 4338465
• MDR Text Key: 21088814
• Report Number: 1825660-2014-00977
• 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: Other
• Type of Report: Initial
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: GRIND NO MORE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other