MAUDE Adverse Event Report: RANIR SNORE GUARD; CLASS I

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Bottom came off (device issue).Case narrative: the snore guard device (class i for reuse) has been identified with a device issue.A female consumer of unknown age had been using the snore guard device for approximately 2-3 weeks when the bottom of the mouth guard came off while in her mouth.The product was stored properly but it remains unknown if the consumer used it properly.The device was operated by the patient.The mouthpiece has been received back by the company and an investigation is being conducted regarding this device (lot #0065).

• Brand Name: SNORE GUARD
• Type of Device: CLASS I
• Manufacturer (Section G): RANIR
• Manufacturer Contact: brian mccormick ; associate director, global pat; ient safety 515 eastern avenue; allegan 49010
• MDR Report Key: 13584062
• MDR Text Key: 289976429
• Report Number: 1811666-2022-00001
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 0065
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Patient Sex: Female