inforMED
InjuryEMA

CEMENT

Received Feb 11, 2020 · Event occurred Oct 31, 2019

Report MW5092950 · MDR key 9699781

Device

Generic name

Cement, Dental

Manufacturer

Unk

Product problems

  • Patient-Device Incompatibility

Patient

71 YR

  • Chest Pain
  • Inflammation
  • Local Reaction
  • Skin Irritation
  • Swelling
  • Shaking/Tremors
  • Chest Pain
  • Inflammation
  • Local Reaction
  • Skin Irritation
  • Swelling
  • Shaking/Tremors

Narrative

Description of Event or Problem

PT CALLED TO REPORT AN ADVERSE REACTION TO A CEMENT USED WHILE GETTING A TEMPORARY CROWN. PT STATED THAT ON (B)(6) 2019, SHE HAD HER FIRST APPT FOR A TEMPORARY CROWN AND BELIEVES SHE HAD A REACTION TO THE CEMENT USED. PT SAID SHE EXPERIENCED SMALL SORES INSIDE HER MOUTH. PT STATED SHE WENT BACK ON (B)(6) 2019, AND THE DENTAL ASSISTANT TOLD HER THEY WERE GOING TO GIVE HER STRONGER CEMENT. PT SAID HER REACTION GOT WORSE, INSIDE HER MOUTH WAS INFLAMED, THE VEINS IN HER MOUTH BECAME SWOLLEN, SHE WAS COLD AND SHAKY, AND HAD CHEST PAIN. PT SUSPECTS THE CEMENT IS WHAT CAUSED HER ADVERSE REACTION.