MAUDE Adverse Event Report: RANIR LLC CVS REST ASSURED GEN. II; MOUTHGUARD, OVER-THE-COUNTER

Model Number REST ASSURED GEN. II 2PK

Device Problem Separation Problem (4043)

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

Event Date 04/03/2019

Event Type  malfunction  

Event Description

Consumer used the guard for the first time and the bottom part fully separated from the top part, he only used the guard once.

• Brand Name: CVS REST ASSURED GEN. II
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer Contact: rebekah stenske ; 4701 east paris ave. se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 8527050
• MDR Text Key: 142786180
• Report Number: 1825660-2019-00542
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091792
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: REST ASSURED GEN. II 2PK
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/03/2019
• Date Manufacturer Received: 04/03/2019
• 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: Initial
• Patient Sequence Number: 1