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

Model Number SNORE GUARD BRAND

Device Problems Loose or Intermittent Connection (1371); Unintended Movement (3026)

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

Event Date 09/22/2017

Event Type  malfunction  

Event Description

Snore guard keeps sliding between the teeth the blue parts are totally damaged.White parts broke due to grinding.Consumer stated it would be more useful to have the blue parts more sturdily attached to the white parts.

• 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 ; 4701 east paris ave. se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 6964547
• MDR Text Key: 90039263
• Report Number: 1825660-2017-00181
• 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: Patient
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SNORE GUARD BRAND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/22/2017
• Date Manufacturer Received: 09/22/2017
• 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