MAUDE Adverse Event Report: SEALANTS (DENTIST); SEALANT, PIT AND FISSURE, AND CONDITIONER

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 03/05/2023

Event Type  Injury  

Event Description

Child experiencing pain since visit to (b)(6) dental for sealants."dentist office in (b)(6)".

• Brand Name: SEALANTS (DENTIST)
• Type of Device: SEALANT, PIT AND FISSURE, AND CONDITIONER
• MDR Report Key: 16674766
• MDR Text Key: 312706319
• Report Number: MW5116263
• Device Sequence Number: 1
• Product Code: EBC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American