PATTERSON PIT AND FISSURE SEALANT - PATTERSON DENTAL SUPPLY
Received Mar 14, 2022 · Event occurred Feb 18, 2022
Report MW5108152 · MDR key 13770468
Device
Generic name
Sealant, Pit And Fissure, And Conditioner.
Manufacturer
Patterson Dental Supply, Inc.Catalog number
089-3990
Lot number
210301
Product problems
- Patient-Device Incompatibility
Patient
Unknown
- Reaction to Medicinal Component of Device
- Reaction to Medicinal Component of Device
Narrative
Description of Event or Problem
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).
Description of Event or Problem
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.