MAUDE Adverse Event Report: PRESTIGE BRANDS INC. MAXIMUM PROTECTION DENTAL GUARD; MOUTHGUARD

Device Problem Entrapment of Device (1212)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

An unknown aged male consumer reported via a social media post experiencing a broken tooth while using the maximum protection dental guard.The consumer started using the maximum protection dental guard, for an unknown amount of time for an unknown indication on an unknown date.After starting the use of the maximum protection dental guard, the patient experienced a broken tooth.The consumer's social media post stated "greetings, about two months ago i purchased your product and i use it regularly, this morning when i took it out half of the tooth was in it.This is very disturbing and i do not know how to take it from here.Please help!".

• Brand Name: MAXIMUM PROTECTION DENTAL GUARD
• Type of Device: MOUTHGUARD
• Manufacturer (Section D): PRESTIGE BRANDS INC.; 660 white plains road; 2nd floor; tarrytown NY 10591
• Manufacturer Contact: vincent argiro ; 660 white plains road; 2nd floor; tarrytown, NY 10591 ; 9145246800
• MDR Report Key: 5707449
• MDR Text Key: 46858941
• Report Number: 3003283852-2016-00002
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• PMA/PMN Number: K091660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2016
• 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