FILLING MATERIAL, TOOTH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-13 for FILLING MATERIAL, TOOTH manufactured by Unk.

Event Text Entries

[67608324] My wife has suffered extreme pain, nausea, vertigo after a tooth filling. This has happened twice before and in each case the tooth in question had to be removed which alleviated the condition. After many medical visits, blood tests, urine samples etc, nothing has been proven as to which drug in the fillings was the culprit. Obviously there is a problem affecting some but not all but in her case this is a serious matter and needs to be investigated. Her suffering is horrendous and trying to outlast the reaction has proven to be useless. Her tooth will have to be removed. There is a chemical reaction problem in filling materials that no one can determine which of the many chemicals are the cause. Thank you. (b)(6). Why was the person using the product: filling a tooth. Other serious/important medical incident: kidney pain, nausea, vertigo. Date the person first started taking or using the product: (b)(6) 2017. Did the problem stop after the person reduced the dose or stopped taking or using the product: no.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5067899
• MDR Report Key: 6331570
• Date Received: 2017-02-13
• Date of Event: 2017-01-11
• Date Added to Maude: 2017-02-15
• 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: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: FILLING MATERIAL, TOOTH
• Generic Name: FILLING MATERIAL, TOOTH
• Product Code: EBD
• Date Received: 2017-02-13
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	2017-02-13