RELYX
Received Jan 4, 2024 · Event occurred Jan 13, 2022
Report MW5149839 · MDR key 18455967
Device
Generic name
Cement, Dental
Patient
65 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
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.