inforMED
InjuryEBF

3M FILTEK COMPOSITE FILLING

Received Jan 10, 2024 · Event occurred Dec 6, 2023

Report MW5150128 · MDR key 18491963

Device

Generic name

Material, Tooth Shade, Resin

Patient

35 YR · Female

  • Hypersensitivity/Allergic reaction
  • Unspecified Infection
  • Itching Sensation
  • Localized Skin Lesion
  • Hypersensitivity/Allergic reaction
  • Unspecified Infection
  • Itching Sensation
  • Localized Skin Lesion

Narrative

Description of Event or Problem

EXTREME ALLERGY TO COMPOSITE FILLINGS FROM 3M, AND FUJI. PATIENT FIRST EXPERIENCED ITCHING, AND LEASIONS. AND THEN MOUTH SORES THAT GOT INFECTED. SEVERAL DIFFERENT BRANDS OF COMPOSITE FILLINGS WERE TRIED, AND SYMPTOMS DID NOT IMPROVE UNTIL HER TEETH WERE RESTORED WITH AMALGAM FILLINGS. REF REPORT: MW5150129.