MAUDE Adverse Event Report: PATTERSON DENTAL SUPPLY, INC. PATTERSON PIT AND FISSURE SEALANT - PATTERSON DENTAL SUPPLY; SEALANT, PIT AND FISSURE, AND CONDITIONER.

Catalog Number 089-3990

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction to Medicinal Component of Device (4574)

Event Date 02/18/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 at 4:50pm patient presented for sealants with mom.Patient was anxious during the procedure, sealants on patient face.We rinse her face and dismissed the patient without completing the procedure.On monday, mother reported to our clinic that she was ok on friday but on saturday morning she has reaction.She was admitted into the hospital.She was dismissed on friday.She had skin reaction saturday morning.Recently talked to father, she is okay now and started going to school.Fda safety report id # (b)(4).

Event Description

Additional information received from reporter on november 6, 2022 for reporter number mw5108152: investigation results: determined to be an allergic reaction, not a defect related to the product.Investigation not required.Skin sensitization is a known and expected side effect if the material is used outside of its indication (on the tooth).As a precaution, this was reported.

• Brand Name: PATTERSON PIT AND FISSURE SEALANT - PATTERSON DENTAL SUPPLY
• Type of Device: SEALANT, PIT AND FISSURE, AND CONDITIONER.
• Manufacturer (Section D): PATTERSON DENTAL SUPPLY, INC.
• MDR Report Key: 13770468
• MDR Text Key: 287401098
• Report Number: MW5108152
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 089-3990
• Device Lot Number: 210301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization