MAUDE Adverse Event Report: DENTEK ORAL CARE, INC. DENTEK TEMPARIN MAX REPAIR KIT; ZINC OXIDE EUGENOL

Device Problem Use of Device Problem (1670)

Patient Problems Dyspnea (1816); Extreme Exhaustion (1843); Headache (1880); Hypersensitivity/Allergic reaction (1907); Dizziness (2194); Shaking/Tremors (2515); Swelling/ Edema (4577)

Event Date 06/17/2023

Event Type  Injury  

Event Description

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.

• Brand Name: DENTEK TEMPARIN MAX REPAIR KIT
• Type of Device: ZINC OXIDE EUGENOL
• Manufacturer (Section D): DENTEK ORAL CARE, INC.
• MDR Report Key: 17217900
• MDR Text Key: 318115928
• Report Number: MW5118875
• Device Sequence Number: 1
• Product Code: EMB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LOSARTAN
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White