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

Lot Number 2007ZZZE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vomiting (2144); Dizziness (2194)

Event Date 02/27/2021

Event Type  Injury  

Event Description

Lightheaded, strange feeling with vomiting within 60 minutes of application.Applied to tooth, some did get on mucosa.Reason for use: patch tooth until dental appt.

• Brand Name: TEMPARIN MAX
• Type of Device: ZINC OXIDE EUGENOL
• Manufacturer (Section D): DENTEK ORAL CARE, INC.
• MDR Report Key: 11453059
• MDR Text Key: 239137820
• Report Number: MW5099871
• Device Sequence Number: 1
• Product Code: EMB
• Combination Product (y/n): Y
• 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: 02/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 2007ZZZE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 63