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

Model Number SNORE GUARD

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/27/2018

Event Type  malfunction  

Event Description

Consumer stated he used the product for the last two years with no issues.I change out every 6-8 months.This one had the top blue portion detach completely from the white tray.He said he didn't even get to really wear the product.As soon as he put it in his mouth he knew it was not right.He threw away the guard so he cant send it back.

• 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: 8262448
• MDR Text Key: 133880222
• Report Number: 1825660-2019-00478
• 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: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• 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: 12/27/2018
• Date Manufacturer Received: 12/27/2018
• 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