MAUDE Adverse Event Report: PRESTIGE BRANDS, INC. THE DOCTOR'S NIGHTGUARD; MOUTHGUARD, OVER-THE-COUNTER

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Pain (1994); Tooth Fracture (2428)

Event Date 03/01/2014

Event Type  Injury  

Event Description

A (b)(6) year old female consumer reported experiencing a broken tooth, tooth pain, a cut on her tongue and a sore tongue while using the doctor's nightguard advance comfort.The consumer reportedly started using the doctor's nightguard advance comfort for protection against bruxism in (b)(6) of 2014.She reported that after two nights she woke up with a broken right upper molar and tooth pain.The consumer reported the nightguard was properly in place when she awoke.She reported that the broken tooth cut her tongue and her tongue was sore.As of this report the broken tooth/tooth pain are ongoing; the cut on her tongue and sore tongue have resolved.The consumer reported that the broken tooth occurred on a saturday when her dentist's office was closed.She followed up with her dentist that monday and he stated that the tooth would have to be replaced.The consumer reported she has begun the process of having the tooth replaced and will be getting a crown.The consumer reported that she takes basic medications; however, she declined to report specific products.

Manufacturer Narrative

• Brand Name: THE DOCTOR'S NIGHTGUARD
• Type of Device: MOUTHGUARD, OVER-THE-COUNTER
• Manufacturer (Section D): PRESTIGE BRANDS, INC.; tarrytown NY 10591
• Manufacturer Contact: 660 white plains road; tarrytown, NY 10591 ; 9145248700
• MDR Report Key: 3815065
• MDR Text Key: 19764916
• Report Number: 2529596-2014-00003
• Device Sequence Number: 1
• Product Code: OBR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/07/2014

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: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNDISCLOSED
• Patient Outcome(s): Other
• Patient Age: 67 YR