MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 3M ESPE CLINPRO WHITE VARNISH; CAVITY VARNISH

Catalog Number	12247BL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Liver Damage/Dysfunction (1954); Patient Problem/Medical Problem (2688)
Date of Event	12/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
3m espe clinpro white varnish (also known as vanish 5% sodium fluoride white varnish) has been thoroughly evaluated for biocompatibility and found to be safe for its intended use.In addition, the global clinical complaint history for this product is favorable, with a low level of total complaints and no observable trends in the types of complaints received.There have been no other reported complaints similar to the current complaint.
Event or Problem Description
On (b)(6) 2017, it was reported to 3m that a (b)(6) female sought emergency medical care and was hospitalized.One week prior the patient received dental treatment involving 3m espe clinpro white varnish (also known as vanish 5% sodium fluoride white varnish), melon flavor and a non-3m product.The patient went home without incident following treatment.A few days later, the patient experienced dark urine, followed by yellow skin pigmentation, at which time emergency medical care was sought.Lab tests were conducted and patient was moved to intensive care.A liver biopsy was taken which resulted in a diagnosis of giant hepatitis cells with little presence of plasma cells.Following the diagnosis, the patient received steroids treatment which stabilized her situation.The patient is currently reported to be stabilized and continues with a treatment regimen of 10mg/day prednisone and 75mg/day immuran.

• Brand Name: 3M ESPE CLINPRO WHITE VARNISH
• Common Device Name: CAVITY VARNISH
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; 2510 conway avenue; st. paul MN 55144 1000
• MDR Report Key: 6815320
• Report Number: 3005174370-2017-00046
• Device Sequence Number: 964087
• Product Code: LBH
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K092141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 08/23/2017

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: Dental Hygienist
• Device Catalogue Number: 12247BL
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 10 YR