RelyX™ 3535Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30605861014015), received between Sep 29, 2017 and Sep 29, 2017 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DENTIST REPORTED THAT A (B)(6) MALE PATIENT EXPERIENCED AN ALLERGIC REACTION THAT INCLUDED LIP SWELLING AND GINGIVAL TISSUE SLOUGHING FOLLOWING USE OF 3M ESPE RELYX LUTING PLUS AUTOMIX CEMENT TO PLACE 6 PORCELAIN-FUSED-TO-METAL CROWNS ON (B)(6) 2017. THE PATIENT SOUGHT MEDICAL ATTENTION THAT SAME EVENING, AT AN EMERGENCY ROOM, AND WAS TREATED WITH IV STEROIDS (UNKNOWN) AND BENADRYL. THE DENTIST SAW THE PATIENT 12 DAYS LATER AND THE SYMPTOMS HAD RESOLVED. THE DENIST REPORTED THAT THE CEMENT WAS OVERLOADED ON THE CROWNS AND CAME IN CONTACT WITH THE GUMS AND GINGIVAL TISSUE, AND HE BELIEVES THAT CAUSED THE REACTION. LATEX GLOVES WERE ALSO USED DURING THE APPOINTMENT, BUT IT IS UNKNOWN IF LATEX MAY HAVE CONTRIBUTED TO THE SYMPTOMS.

  Patient problems: Swelling; Tissue Breakdown

  MAUDE report 6906290 ↗