MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 3M¿ FAST RELEASE VARNISH; VARNISH, CAVITY

Model Number	12158S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Burning Sensation (2146); Swelling/ Edema (4577)
Date of Event	01/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample was returned for analysis and not lot number was provided.The instructions for use for 3m fast release varnish contains a precautionary statement that patients with known sensitivity to colophony/rosin should avoid this product.
Event or Problem Description
Swelling of the lip, redness of the tongue and burning sensation throughout the body was alleged the morning after application of 3m fast release varnish, 5% sodium fluoride, strawberry flavor.The swelling continued the next few days, including the hands.The dentist prescribed prednisone (6- day cycle), after which the symptoms reduced but continued.The patient planned on seeing a dermatologist.No further information is available.
Additional Manufacturer Narrative
No sample was returned for analysis and not lot number was provided.The instructions for use for 3m fast release varnish contains a precautionary statement that patients with known sensitivity to colophony/rosin should avoid this product.
Event or Problem Description
Swelling of the lip, redness of the tongue and burning sensation throughout the body was alleged the morning after application of 3m fast release varnish, 5% sodium fluoride, strawberry flavor.The swelling continued the next few days, including the hands.The dentist prescribed prednisone (6- day cycle), after which the symptoms reduced but continued.The patient planned on seeing a dermatologist.No further information is available.

• Brand Name: 3M¿ FAST RELEASE VARNISH
• Common Device Name: VARNISH, CAVITY
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; 2510 conway avenue; st. paul MN 55144 1000
• Manufacturer (Section G): ORATECH LLC; 10075 south jordan gateway; south jordan UT 64095
• Manufacturer Contact: suzanne leung ; 2510 conway avenue; building 275-02-w-08; st. paul, MN 55144-1000 ; 6515758052
• MDR Report Key: 13389270
• Report Number: 3005174370-2022-00001
• Device Sequence Number: 4858609
• Product Code: LBH
• UDI-Device Identifier: 30605861060678
• UDI-Public: 30605861060678
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132109
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2022

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
• Operator of Device: Health Professional
• Device Model Number: 12158S
• Device Catalogue Number: 12158S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male