MAUDE Adverse Event Report: PRESTIGE BRANDS INC. DENTEK DENTAL GUARD MAXIMUM PROTECTION; MOUTHGUARD, OVER-THE-COUNTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  No Answer Provided  

Event Description

A (b)(6) year old male consumer reported via phone experiencing teeth loss, pressure from guard and teeth decay while using maximum protection dental guard.The consumer reported he started using the maximum protection dental guard for seven to eight years for teeth grinding and nail biting.On an unknown date in 2014 and 2015 after starting maximum protection dental guard, the consumer experienced tooth loss, pressure from guard and teeth decay.The consumer lost two side teeth in the last two years, one tooth in 2014 and one in 2015, because they had got rotten where the guard presses the most.The consumer is not sure if what he experienced is due to the dental guard or something else but stated he brushes his teeth well.At the time of this report, the teeth loss, pressure from guard and teeth decay have resolved.

• Brand Name: DENTEK DENTAL GUARD MAXIMUM PROTECTION
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): PRESTIGE BRANDS INC.; 660 white plains road; tarrytown NY 10591
• Manufacturer Contact: vincent argiro ; 660 white plains road; tarrytown, NY 10591 ; 9145246800
• MDR Report Key: 5624695
• MDR Text Key: 44335943
• Report Number: 3003283852-2016-00001
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091660
• 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: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 05/03/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR