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

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

Patient Problem Foreign Body In Patient (2687)

Event Date 04/17/2015

Event Type  Injury  

Manufacturer Narrative

Initial report was completed on 05/16/15.This follow up report is being completed to correct the patient identifier submitted in the 05/16/2015 report; the numbers were inadvertently transposed on the initial complaint.

Event Description

He called on behalf of his wife who believed she swallowed it in her sleep.He wondered if there would be any problem with passing it.

Manufacturer Narrative

Initial report was completed on 05/16/2015.This follow up report is being completed to correct the patient identifier submitted in the 05/16/2015 report; the numbers were inadvertently transposed on the initial complaint.Device not returned.

Event Description

He called on behalf of his wife who believed she swallowed it in her sleep.He wondered if there would be any problem with passing it.

• Brand Name: GRIND NO MORE
• Type of Device: BRUXISM MOUTH GUARD
• Manufacturer (Section D): RANIR LLC; 4701 east paris se; grand rapids MI 49512 5353
• Manufacturer (Section G): RANIR LLC; 4701 east paris se; grand rapids MI 49512 5353
• Manufacturer Contact: elsa baker ; 4701 east paris ave se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 4788958
• MDR Text Key: 167435791
• Report Number: 1825660-2015-00026
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K094020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: No
• 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