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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MINNESOTA, MINING & MANUFACTURING / 3M ESPE DENTAL PRODUCTS RELYX; CEMENT, DENTAL
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MINNESOTA, MINING & MANUFACTURING / 3M ESPE DENTAL PRODUCTS RELYX; CEMENT, DENTAL Back to Search Results
Patient Problem Insufficient Information (4580)
Event Date 01/13/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, i was fitted with a "permanent crown" by the provider.I asked for a product insert, but never received one.I was not informed of the mfr until after the procedure.On (b)(6) 2022, the product described as a zirconium crown was inserted and cemented with relyx n.V.#15, a 3m product.I was not informed of the specific products being used.After the procedure, i was asked to sign a statement on the medical chart: "pt happy with shade, shape and fit."x" where i did not give informed consent to use any 3m product (relyx luting 2 resin modified glass lanomer cement.Had i known this was being used, i would have refused the procedure because of the deleterious effects of their silicone breast implants and their lack of ethical consumerism.I feel duped for political gain after having lodged a prior complaint.
 
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Brand Name
RELYX
Type of Device
CEMENT, DENTAL
Manufacturer (Section D)
MINNESOTA, MINING & MANUFACTURING / 3M ESPE DENTAL PRODUCTS
MDR Report Key18455967
MDR Text Key332270351
Report NumberMW5149839
Device Sequence Number1
Product Code EMA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient Outcome(s) Disability; Other; Required Intervention;
Patient Age65 YR
Patient SexFemale
Patient Weight82 KG
Patient EthnicityNon Hispanic
Patient RaceWhite, American Indian Or Alaskan Native
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