MAUDE Adverse Event Report: RANIR LLC LIFE BRAND; MOUTHGUARD, OVER-THE-COUNTER

Model Number MTH GD RST ASRD W/TRAY 2CT CRTN BILINGUAL

Device Problems Structural Problem (2506); Torn Material (3024)

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

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Consumer threw out the product.

Event Description

Consumer stated he "followed instructions but the process didn't work well.The gel got stuck to the dental protector, in one of the two insistence it tore in half." consumer sent pictures, he threw the guard out.

Manufacturer Narrative

Correcting product code: previously reported as snore guard/lrk.Corrected to life brand/obr and 501k number.

Event Description

Consumer stated he "followed instructions but the process didn't work well.The gel got stuck to the dental protector, in one of the two insistence it tore in half." consumer sent pictures, he threw the guard out.

• Brand Name: LIFE BRAND
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• 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
• MDR Report Key: 7620583
• MDR Text Key: 112162599
• Report Number: 1825660-2018-00356
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MTH GD RST ASRD W/TRAY 2CT CRTN BILINGUAL
• Device Lot Number: 190240B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/24/2018
• Date Manufacturer Received: 05/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1