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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M RELYX PLUS LUSTING CEMENT ESPE; CEMENT DENTAL

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3M RELYX PLUS LUSTING CEMENT ESPE; CEMENT DENTAL Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Burn(s) (1757); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Pain (1994); Swelling (2091); Swollen Lymph Nodes (2093); Complaint, Ill-Defined (2331); Reaction (2414)
Event Date 11/25/2014
Event Type  Injury  
Event Description
Dentist used 3m espe's relyx plus fluting cement that contains fluoride to cement a permanent crown.This was after patient reported to the dental office that she had a severe allergic reaction to fluoride varnish that same dental office applied 3weeks prior.Lips had swelled and burned plus patient had extreme pain in tooth and jaw necessitating 2 visits to urgent care.On second visit, patient received torodol shot for pain.Patient asked dental office manager if the cement could be tested in advance to see if patient had similar reaction.Manager was not concerned and said this product did not contain the same kind of fluoride as the varnish.The dentist had previously told patient he did not believe allergy testing was effective.When cement was applied, patient had extreme burning pain on the tooth for 2 hours.Patient called dental office repeatedly to report the problem and they told her not to rinse for 2 hours so the cement could cure.Patient also called manufacturer 3m espe to report the problem and seek advice from their toxicologist.Toxicologist would not provide any advice about side effects or how to deal with them but instead looked for excuses for other sources of the patient's pain.3m would only say that patient should ask the dentist (who has limited experience with patients compared to manufacturer experience) for advice.Toxicologist claimed the product was fda approved, although it does not require testing and approval like a drug.Patient subsequently found studies conducted by dental schools including (b)(6) citing relyx plus as cytotoxic and should be avoided particularly in cases where remaining tooth structure is small.Patient continued to have pain in tooth and jaw although roots still tested as normal by endodontist on (b)(6) 2014.Periodontal exam on (b)(6) 2014 revealed enlarged lymph node just below jaw and patient had high blood pressure of 149.Subsequent ultrasound imaging on (b)(6) 2014 did not show a reactive lymph node.Blood pressure continued to monitor as much higher than normal for this patient and patient had recurring abdominal pain and burning and fatigue standing.On (b)(6) patient had recurring pain and swelling in roof of mouth.Patient continues to seek medical and dental care.
 
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Brand Name
RELYX PLUS LUSTING CEMENT ESPE
Type of Device
CEMENT DENTAL
Manufacturer (Section D)
3M
MDR Report Key4364986
MDR Text Key14881358
Report NumberMW5039805
Device Sequence Number1
Product Code EMA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age62 YR
Patient Weight50
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