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

Model Number SNORE GUARD

Device Problem Material Integrity Problem (2978)

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

Event Date 04/07/2020

Event Type  malfunction  

Event Description

Consumer stated the snore-guard fit properly but it unfortunately does not last long.Consumer returned snore-guard and bottom bite piece was completely detached.

• 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 stenske ; 6166988880
• MDR Report Key: 10021343
• MDR Text Key: 190513377
• Report Number: 1825660-2020-00759
• Device Sequence Number: 1
• Product Code: LRK
• UDI-Device Identifier: 00071031987554
• UDI-Public: 071031987554
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SNORE GUARD
• Device Lot Number: 7360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Distributor Facility Aware Date: 04/07/2020
• Date Manufacturer Received: 04/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1