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

Model Number SNORE GUARD BRAND

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Loose or Intermittent Connection (1371)

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

Event Date 09/07/2017

Event Type  malfunction  

Event Description

Consumer stated the bottom part impressions were not deep enough.The bottom then becomes loose and blue part falls off on bottom.

• 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: 6910210
• MDR Text Key: 88151559
• Report Number: 1825660-2017-00166
• 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: 10/03/2017

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 BRAND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/07/2017
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 10/03/2017
• 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