inforMED
InjuryEMB

DENTEK TEMPARIN MAX REPAIR KIT

Received Jun 27, 2023 · Event occurred Jun 17, 2023

Report MW5118875 · MDR key 17217900

Device

Generic name

Zinc Oxide Eugenol

Product problems

  • Use of Device Problem

Patient

55 YR · Female

  • Dyspnea
  • Extreme Exhaustion
  • Headache
  • Hypersensitivity/Allergic reaction
  • Dizziness
  • Shaking/Tremors
  • Swelling/ Edema
  • Dyspnea
  • Extreme Exhaustion
  • Headache
  • Hypersensitivity/Allergic reaction
  • Dizziness
  • Shaking/Tremors
  • Swelling/ Edema

Narrative

Description of Event or Problem

I USED DENTEK TO APPLY TO A CRACKED TOOTH, BEFORE GOING TO BED. THE NEXT MORNING I WAS DIZZY, SHORT OF BREATH, SHAKING, HEADACHE, AND I FELT EXHAUSTED, MY TONGUE, THROAT AND MOUTH WAS SWOLLEN AND RAW. AFTER REALIZING THAT THE DENTEK WAS THE ONLY THING I HAD DONE DIFFERENT, I REMOVED IT FROM MY TOOTH, HOWEVER THE EFFECTS L EXPERIENCED FOR 5 DAYS AFTERWARD. AND BECAUSE OF THE SYMPTOMS I WAS UNABLE TO GO TO WORK. SLOWLY THINGS HAVE RETURNED TO NORMAL BUT I WILL NEVER USE THIS PRODUCT AGAIN.