ESTHET X COMPOSITE RESIN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-05 for ESTHET X COMPOSITE RESIN manufactured by Dentsply.

Event Text Entries

[878672] I have celiac disease - requiring lifelong adherence to a gluten-free diet and lifestyle, so that my intestine doesn't attack itself again-. I had my first dental composite put in my mouth a month ago, after a mercury molar filling was removed - using dental dam and suction precautions-, and have had celiac reactions ever since to the composite. Normally i am free of symptoms, but i am now experiencing chronic abdominal pain, bloating, gas and very infrequent bowel movements. I have not been able to get ingredient lists from mfrs to determine whether gluten is the cause - which i'm sure it is -, and wonder whether there are any dental companies able to guarantee that no gluten is used in the production or mfr of their materials. So far, i haven't had any luck finding any. My dentist does not know what to replace my composite resin with, and so i am at a loss of what to do. Thank you for your time and any info or advice you can provide. P. S. I would like to avoid mercury as i am of childbearing age. Sincerely, desperate for relief. Dose or amount: used in filling, using in filling. Frequency: presently in mouth. Route: dental. Dates of use: 2008. Diagnosis or reason for use: replacement of chipped amalgam.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5007528
• MDR Report Key: 1069886
• Date Received: 2008-07-05
• Date of Report: 2008-07-05
• Date of Event: 2008-06-05
• Date Added to Maude: 2008-07-11
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ESTHET X COMPOSITE RESIN
• Generic Name: RESIN
• Product Code: OIV
• Date Received: 2008-07-05
• Device Availability: N
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 1038261
• Manufacturer: DENTSPLY

Device Sequence Number: 2

• Brand Name: ESTHET X COMPOSITE TENURE
• Generic Name: TENURE
• Product Code: EBF
• Date Received: 2008-07-05
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 2
• Device Event Key: 1038262
• Manufacturer: ENTSPLY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2008-07-05