UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-01-03 for UNK * manufactured by Unk.

Event Text Entries

[19960645] Rptr became almost totally unable to mentally function from a reaction to a glue or other material used to temporarily cement a cap in. The effect was one of being immobilized, a catatonic type state. The materials dissolved and rptr was ingesting them. Sweating and hormonal reactions also. Relief was immediate when the cap fell off. The dissolving of the materials leads rptr to believe a durg (or chemical) interaction caused by synergistic effects of combined chemicals or metals. Rptr was further shocked to learn that dental records of materials used are not required by law. Rptr has chemical sensitivity, but has never reacted to dental adhesives before. This same reaction occurred on more than one occassion. Removal of product resolved problem. Product should be tested for use with other chemicals. Other symptoms included chemicals taste, burning in mouth, throat swelling, and heavy feeling. More attention needs to be given to educate pts and dentists about side effects, etc; and complete dental records must be kept. Rptr claims aggrevation of disability.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1015432
• MDR Report Key: 205947
• Date Received: 1999-01-03
• Date of Report: 1999-01-01
• Date of Event: 1998-01-01
• Date Added to Maude: 1999-01-14
• 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
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UNK
• Generic Name: DENTAL CEMENT
• Product Code: EMB
• Date Received: 1999-01-03
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 199913
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit	1999-01-03