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

Model Number SNORE GUARD

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/25/2021

Event Type  malfunction  

Event Description

Consumer stated on survey "the snore guard broke on the 3rd night.I tried to fix it with no luck." snoreguard returned.

• 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: 11579311
• MDR Text Key: 243784463
• Report Number: 1825660-2021-00925
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Distributor Facility Aware Date: 02/25/2021
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/27/2021
• 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