SNORE GUARD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-01 for SNORE GUARD manufactured by Ranir Llc.

Event Text Entries

[137975006] Consumer asked if she could wear the snoreguard with a crown on her tooth. Advised the consumer speak to her dentist first. Consumer responded next day and said her tooth crown was lose and wanted a refund for the product.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1825660-2019-00513
• MDR Report Key: 8381932
• Date Received: 2019-03-01
• Date of Report: 2019-03-01
• Date of Event: 2019-02-01
• Date Facility Aware: 2019-02-25
• Date Mfgr Received: 2019-02-25
• Date Added to Maude: 2019-03-01
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: REBEKAH STENSKE
• Manufacturer Street: 4701 EAST PARIS AVE. SE
• Manufacturer City: GRAND RAPIDS MI 495125353
• Manufacturer Country: US
• Manufacturer Postal: 495125353
• Manufacturer Phone: 6166988880
• Manufacturer G1: RANIR LLC
• Manufacturer Street: 4701 EAST PARIS AVE. SE
• Manufacturer City: GRAND RAPIDS MI 495125353
• Manufacturer Country: US
• Manufacturer Postal Code: 495125353
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: SNORE GUARD
• Generic Name: DEVICE, ANTI-SNORING
• Product Code: LRK
• Date Received: 2019-03-01
• Model Number: SNORE GUARD
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RANIR LLC
• Manufacturer Address: 4701 EAST PARIS AVE. SE GRAND RAPIDS MI

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-03-01