3M ESPE RELYX LUTING PLUS CEMENT AUTOMIX PASTE A+ B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-22 for 3M ESPE RELYX LUTING PLUS CEMENT AUTOMIX PASTE A+ B manufactured by 3m Dental.

Event Text Entries

[53379932] Approximately 5 years ago in 2011, i had 2 three unit bridges and 2 crowns placed in my mouth. According to my dentist the materials used were 3m espe relyx luting plus cement automix paste a + b msds sheets dated (b)(6) 2011 ((b)(4)). When requested from my dentist, he only submitted to me pages 1 of 6 and did not send me the additional 5 that showed the health hazards and potential health effects. Ever since placement, i have experienced severe declining health including numerous food and chemical allergies, sensitization on my face and scalp to the point i cannot use any make up or shampoo or put anything on my face from the neck up without having reactions. I am completely sensitized and i am also unable to brush my teeth or touch my teeth and swollen gums without headaches and dizziness. I have developed a severe corn intolerance and unable to eat pretty much anything or take any medications that aren't compounded since corn is in absolutely everything. Some of the ingredients in these cements are in fact corn derived (hema, benzeethanol) which of course the company refuses to confirm or deny stating it's proprietary. The worst offenders of these materials include hema, bht and copolymer of acrylic and itaconic acids and per the msds sheets, the hazards are frightening. If it advises to wear goggles for exposure and full protective gear with a breathing apparatus for firefighters how is this ok to put in my mouth? These chemicals are known toxins and bht is banned in other countries. After years going from doctor to doctor, being tested for everything under the sun, i am showing a positive inflammation in my bloodwork and being told nothing is wrong because no one has looked in the right place which is my mouth. I have finally been able to connect the dots and i am waiting to have the materials replaced after spending thousands of dollars on restorative treatment that was medically necessary. I am hoping to redeem my immune system and go back to work. It is appalling to me that these types of chemicals stating the potential adverse health effects are allowed on the market.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5064315
MDR Report Key5903381
Date Received2016-08-22
Date of Report2016-08-22
Date Added to Maude2016-08-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand Name3M ESPE RELYX LUTING PLUS CEMENT AUTOMIX PASTE A+ B
Generic Name3M ESPE RELYX LUTING PLUS CEMENT AUTOMIX PASTE A+ B
Product CodeDYH
Date Received2016-08-22
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
Manufacturer3M DENTAL


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2016-08-22

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