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

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

Device Problems Break (1069); Crack (1135)

Patient Problem No Information (3190)

Event Date 07/14/2017

Event Type  malfunction  

Event Description

(b)(4).Customer is claiming that he broke, cracked the eq night protector by accident.Customer did not provide an exp date.

• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave se; grand rapids MI 49512
• Manufacturer Contact: brenda mumbower ; 4701 east paris ave se; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 6794844
• MDR Text Key: 82938438
• Report Number: 1825660-2017-00135
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Device Unattended
• Device Model Number: MTH GD RST ASRD W/TRAY 2CT CD
• Device Lot Number: 191608 A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/17/2017
• Date Manufacturer Received: 07/17/2017
• Type of Device Usage: N
• Patient Sequence Number: 1