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 2019-02-28 for SNORE GUARD manufactured by Ranir Llc.

Event Text Entries

[138094283] The bottom part sunk down and the plastic chipped a bit. I need to adjust to align with my teeth. Consumer returned a second guard. Report 2 of 2.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1825660-2019-00510
• MDR Report Key: 8379744
• Date Received: 2019-02-28
• Date of Report: 2019-02-28
• Date of Event: 2019-01-31
• Date Facility Aware: 2019-01-31
• Date Mfgr Received: 2019-01-31
• Date Added to Maude: 2019-02-28
• 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: 2019-02-28
• Returned To Mfg: 2019-01-31
• Model Number: SNORE GUARD
• Lot Number: 7258
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RANIR LLC
• Manufacturer Address: 4701 EAST PARIS AVE. SE GRAND RAPIDS MI 495125353 US 495125353

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-02-28