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

Model Number GRIND NO MORE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/16/2014

Event Type  Injury  

Event Description

Stated he swallowed the guard last night and doesn't know if he should go to the doctor.Is it harmful to his body?.

Manufacturer Narrative

Consumer stated he swallowed the guard last night and doesn't know if he should go to the doctor.Is it harmful to his body?.

• 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: 4190623
• MDR Text Key: 5099434
• Report Number: 1825660-2014-00929
• 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: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 10/21/2014
• 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