MAUDE Adverse Event Report: RANIR LLC GRIND NO MORE; BRUXISM MOUTHGUARD

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

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

Event Date 01/20/2015

Event Type  malfunction  

Event Description

Consumer rinsed it with cold water and now it won't adjust.There looks to be a "tear" where the slot is and it is "ripping somehow.".

Manufacturer Narrative

Device not received back.

• Brand Name: GRIND NO MORE
• Type of Device: BRUXISM MOUTHGUARD
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave se; grand rapids MI 49512 535
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave se; grand rapids MI 49512 535
• Manufacturer Contact: elsa baker ; 4701 east paris se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 4532969
• MDR Text Key: 5506174
• Report Number: 1825660-2015-00011
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112879
• 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: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/23/2014
• Event Location: Home
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1