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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 03/08/2015

Event Type  Injury  

Event Description

Though they worked, they caused my teeth to shift around, and moved them so much that my front teeth have pushed into each other and are trying to pass each other.

• Brand Name: PLACKERS GRIND NO MORE
• Type of Device: BRUXISM DEVICE
• Manufacturer (Section D): RANIR LLC; 4701 east paris se; grand rapids MI 49512 535
• Manufacturer (Section G): RANIR LLC; 4701 east paris se; grand rapids MI 49512 535
• Manufacturer Contact: elsa baker ; 4701 east paris ave se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 4621698
• MDR Text Key: 5588359
• Report Number: 1825660-2015-00052
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Device Unattended
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2015
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1