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

Model Number SNORE GUARD

Device Problems Deformation Due to Compressive Stress (2889); Material Deformation (2976)

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

Event Date 10/05/2018

Event Type  malfunction  

Event Description

Consumer stated the bottom teeth was off center and so he tried to re center.He believes he bit too hard bottom part.Spoke to consumer and he said he reboiled it.When he tried to refit it, he bite down and the bottom part fell off.He threw away the product.

• Brand Name: SNORE GUARD
• Type of Device: DEVICE, ANTI-SNORING
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer Contact: rebekah stenske ; 4701 east paris ave. se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 7991744
• MDR Text Key: 125322555
• Report Number: 1825660-2018-00436
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103004
• 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: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• 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: 10/09/2018
• Date Manufacturer Received: 10/09/2018
• 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