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
Manufacturer
Dentek Oral Care, Inc.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.