MAUDE Adverse Event Report: RANIR LLC READY TO WEAR DENTAL PROTECTOR; BRUXISM DEVICE

Device Problem Insufficient Information (3190)

Patient Problem Abdominal Pain (1685)

Event Date 09/16/2015

Event Type  No Answer Provided  

Event Description

Customer stated that he has belly aches when he wakes up and wonders if he swallowed the mouthguard or if he has cancer.

• Brand Name: READY TO WEAR DENTAL PROTECTOR
• Type of Device: BRUXISM DEVICE
• 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: 5144492
• MDR Text Key: 28043322
• Report Number: 1825660-2015-00056
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Device Unattended
• Remedial Action: Patient Monitoring
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other