MAUDE Adverse Event Report: GLAXOSMITHKLINE BIOTENE DRY MOUTH ORAL RINSE

Lot Number 6D14C2A

Device Problem Device Slipped (1584)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/01/2016

Event Type  Injury  

Event Description

I used biotene dry mouth oral rinse for 4 days, i noticed on the 3rd day my teeth seemed sensitive to drinks.By the 4th day, it hurts to even touch my teeth.By the end of that day, part of my filling had fell out.It took almost a week for my teeth to feel normal again.Dose or amount: tablespoon.Frequency: twice a day.Route: taken by mouth.Dates of use: (b)(6) 2016.

• Brand Name: BIOTENE DRY MOUTH ORAL RINSE
• Type of Device: BIOTENE DRY MOUTH ORAL RINSE
• Manufacturer (Section D): GLAXOSMITHKLINE
• MDR Report Key: 5725460
• MDR Text Key: 47417773
• Report Number: MW5062841
• Device Sequence Number: 1
• Product Code: NTO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 6D14C2A
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 136