MAUDE Adverse Event Report: RANIR, LLC REST ASSURED, GEN II; MOUTH GUARD

Model Number REST ASSURED, GEN II

Device Problems Break (1069); Delamination (2904)

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

Event Date 08/26/2014

Event Type  malfunction  

Event Description

I'm calling about the grind guard.I just had a question.I'd been using it and now it seems to have broken.After speaking directly with the consumer it appears that the device has delaminated.

Manufacturer Narrative

I'm calling about the grind guard.I just had a question.I'd been using it and now it seems to have broken.After speaking directly with the consumer it appears that the device has delaminated.

• Brand Name: REST ASSURED, GEN II
• Type of Device: MOUTH GUARD
• 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: 4107712
• MDR Text Key: 4716959
• Report Number: 1825660-2014-00918
• 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: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: REST ASSURED, GEN II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2014
• 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