MAUDE Adverse Event Report: 3M VITREBOND ; CEMENT, DENTAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Peeling (1999); Skin Irritation (2076); Reaction (2414); Skin Tears (2516); No Code Available (3191)

Event Date 01/01/1989

Event Type  Injury  

Event Description

My first allergic reaction to 2-hydroxyethylmethacrylate was around 1989/1990 when i was a sales rep for 3m dental products group in (b)(6).Vitrabond was introduced to the marketplace and i believe it was the first product 3m produced using hema.My fingers sloughed skin, especially the fingertips and produced bleeding, followed by cracking of the skin and peeling.I eventually lost my fingerprints.As it was impossible to work and demonstrate, i was sent to a skin specialist just outside (b)(6) who undertook patch testing on various products on my arm until the offending product was established.In 1992, i came to live in the u.S.A.And started working in medical imaging for 3m away from the risk of products.I came back to the (b)(6) in 1999 and had to undergo left hip replacement at (b)(6) hospital outside (b)(6).When undergoing consultation, the procedure was explained and it was mentioned that i may need cementing of the shaft during surgery.Knowing that cements used were similar in nature to dental cements i discussed my allergy re hema.It was decided at that time not to use cement which resulted in my left leg being 1/2 an inch longer than my right.I returned to the u.S.A.In 2001 and once again worked in dental sales being responsible for all the dental school (b)(6).I worked with many faculty members who at that time were researching allergic reaction to materials.In 2008, my left hip again needed replacement and i had to be diligent in making sure no cements containing hema were used and i had a successful result, although the 1/2 difference is still there.Around 2011, i needed cataract surgery and after research, discovered that the minute brackets that held the lenses also contained hema.So thankfully i was able to avoid a problem should they have been used.Over the years i have, through necessity become somewhat of an expert on hema and always made sure that any dentist i attended was made aware of my allergy.In 2013, it was discovered i had a double brain aneurysm on my right carotid artery.This was coiled at (b)(6) hospital and the following day i had a reaction on my face and chest.I did more research and discovered that hema is also in contrast mediums and following my surgery had an angiogram to access the success of the procedure.Here contrast medium was used and as i have to undergo that procedure on a regular basis i now have to be medicated using 3 different drugs to counteract the reaction.Yet, despite this i have a reaction the following day on face and chest.Hopefully this explains how serious my hema allergy has become and felt that it was time i reported it to the fda.'did the problem stop after the person reduced the dose or stopped taking or using the product: no.Did the problem return if the person started taking or using the product again: yes.Do you still have the product in case we need to evaluate it: no.Is the product over-the-counter: no.'.

• Brand Name: VITREBOND
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): 3M
• MDR Report Key: 6356392
• MDR Text Key: 68413047
• Report Number: MW5068102
• Device Sequence Number: 1
• Product Code: EMA
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 70 YR
• Patient Weight: 54