MAUDE Adverse Event Report: RANIR LLC SNORE GUARD; DEVICE, ANTI-SNORING

Model Number SNORE GUARD

Device Problems Material Separation (1562); Defective Component (2292)

Patient Problem No Information (3190)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

Product was not returned, (b)(4).Capa is currently in process for issue.

Event Description

Consumer stated: "it's kind of falling apart after about week.It works really well, and both my wife and i are very happy.Except for one problem - the bottom part of it, where the smaller silicon/plastic for the teeth is, is separating from the hard plastic form that holds it.It becomes a problem, because both the teeth and the tongue are now uncomfortable when i sleep, to a point where it almost cuts into the tongue.I would love to receive a replacement, because i am hoping it is a simple defect, as the unit is working very well aside from this problem.".

• Brand Name: SNORE GUARD
• Type of Device: DEVICE, ANTI-SNORING
• 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: 7499174
• MDR Text Key: 107960571
• Report Number: 1825660-2018-00316
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103004
• 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: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SNORE GUARD
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/18/2018
• Date Manufacturer Received: 04/18/2018
• 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