COE-SOFT™ 344011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D6583440111), received between Nov 3, 2016 and Jun 1, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  GC AMERICA INC. (GCA) RECEIVED REPORT MW5068722 FROM FDA'S MEDWATCH PROGRAM ON 20 APR 2017. THE PATIENT WAS PRESENT AT A DENTAL OFFICE AND UNDER THE CARE OF A FEMALE DENTIST. WHEN AT OR SHORTLY AFTER 3 PM, THE DENTIST APPLIED A DENTAL PRODUCT KNOWN AS THE BRAND-NAME "COE-SOFT" USED AS A TEMPORARY DENTURE LINER. THE PATIENT EXPERIENCED THE FOLLOWING SYMPTOMS: SINUS INFLAMMATION, ADRENALINE RUSH, FAST HEART RATE (POUNDING HEART), THROAT SCRATCHINESS AND STIFFNESS WITH DIFFICULTY SWALLOWING, TIGHTNESS IN THE CHEST, AND INABILITY TO TAKE A FULL BREATH. THE PATIENT INSTRUCTED THE DENTIST TO CALL 911 FOR THE ALLERGIC REACTION. 'NAME WITHHELD' RESPONDED BECAUSE AN AMBULANCE WAS NOT CLOSE ENOUGH. THE AMBULANCE ARRIVED AND TRANSPORTED THE PATIENT TO A HOSPITAL WHERE TREATMENT WAS STARTED AND COMPLETED WITH 50 MG OF BENADRYL BY MOUTH, 40 MG OF PREDNISONE BY MOUTH, 10 MG OF FAMOTIDINE BY MOUTH. SYMPTOMS TOOK 4 TO 4.5 HOURS TO SUBSIDE ONCE TREATMENT WAS STARTED. NO ADDITIONAL INFORMATION WAS OBTAINED.

  Patient problems: Chest Tightness/Pressure; Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 6605335 ↗
• InjuryNov 3, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  GC AMERICA INC. (GCA) RECEIVED REPORT MW5065490 FROM FDA ON 27 OCT 2016. THE PATIENT HAD VOLUNTARILY REPORTED AN EVENT THROUGH FDA'S MEDWATCH PROGRAM ON 17 OCT 2016. THE PATIENT REPORTED THE FOLLOWING SYMPTOMS AFTER PROCEDURE AT A DENTAL PROVIDER WITH COE-SOFT, A RELINE MATERIAL: MOUTH STINGING, TONGUE SWELLING AND STINGING, LIPS SORE, MOUTH RED, BLISTERY RASH AROUND MOUTH, HEAD FELT AS IF ON FIRE, SINUSES STINGING, AND LOOSE, CLEAR DRAINAGE. GCA WAS NOT AWARE OF THIS EVENT UNTIL AFTER RECEIVING THE REPORT. GCA CALLED THE PATIENT BACK ON 27 OCT 2016 FOR FOLLOW UP. THE PATIENT STATED THE NAME OF THEIR DENTAL PROVIDER. THE PATIENT STATED THEY WERE ALLERGIC TO LATEX AND WERE CONCERNED ABOUT INGREDIENTS IN COE-SOFT PRODUCT. THE PATIENT STATED THEY HAD AN IMMEDIATE DENTURE PLACED ON (B)(6) 2016 WITH A FEW TEETH EXTRACTED. THE PATIENT STATED THEY WENT BACK TO THEIR DENTAL PROVIDER A WEEK LATER WITH SOME SORE EARS IN THEIR MOUTH. THE DENTAL PROVIDER PLACED A RELINE MATERIAL TO HELP FIT THE DENTURES. THE PATIENT STATED THEY HAD NOTICED A FEW SMALL BITS OF RELINE ON THEIR FACE AND RINSED IT OFF AT THE DENTAL PROVIDER'S PRACTICE. THE PATIENT NOTICED A RASH ON THEIR FACE THE NEXT DAY AND ALSO

  Patient problems: Hypersensitivity/Allergic reaction; Swelling

  MAUDE report 6075774 ↗