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

Model Number SNORE GUARD

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2021

Event Type  malfunction  

Event Description

Pharmacist called on behalf of the consumer.Consumer stated the snoreguard broke in his mouth, he just bought it.No further details provided as to what part broke and the product was not returned as requested.

• Brand Name: SNOREGUARD
• 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 hamilton ; 6166988880
• MDR Report Key: 11530095
• MDR Text Key: 242970971
• Report Number: 1825660-2021-00921
• Device Sequence Number: 1
• Product Code: LRK
• UDI-Device Identifier: 00071031987554
• UDI-Public: 071031987554
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• 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: 02/18/2021
• Date Manufacturer Received: 02/18/2021
• 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