MAUDE Adverse Event Report: RANIR LLC RITE AID; MOUTHGUARD, OVER-THE-COUNTER

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

Device Problems Break (1069); Component Falling (1105); Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 06/20/2017

Event Type  malfunction  

Event Description

Product not good.Too flimsy.Breaks, loose, falls out.

• Brand Name: RITE AID
• 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 ; 6166988880
• MDR Report Key: 6720721
• MDR Text Key: 80303934
• Report Number: 1825660-2017-00120
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• PMA/PMN Number: K133423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MTH GD RST ASRD W/TRAY 2CT CRTN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/20/2017
• Date Manufacturer Received: 06/20/2017
• 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