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

Model Number SNORE GUARD

Device Problem Crack (1135)

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

Event Date 07/02/2019

Event Type  malfunction  

Event Description

Reporter stated her husband has been using snore guards for a few years but on the last guard he used, the "bottom part of the guard cracked" which the consumer believed to be a choking hazard.Consumer also wondered how long the guard should be used.As consumer was reporting it past tense, the product was no longer available for review.

• 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: 8832363
• MDR Text Key: 167639181
• Report Number: 1825660-2019-00586
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• 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: 07/03/2019
• Date Manufacturer Received: 07/03/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1