MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2017-08-23 for 3M ESPE CLINPRO WHITE VARNISH 12247BL manufactured by 3m Espe Dental Products.
[83456378]
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.
Patient Sequence No: 1, Text Type: N, H10
[83456379]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00046 |
| MDR Report Key | 6815320 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2017-08-23 |
| Date of Report | 2017-08-23 |
| Date of Event | 2016-12-27 |
| Date Mfgr Received | 2017-08-16 |
| Date Added to Maude | 2017-08-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANGIE DRAPER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Manufacturer G1 | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 551441000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M ESPE CLINPRO WHITE VARNISH |
| Generic Name | CAVITY VARNISH |
| Product Code | LBH |
| Date Received | 2017-08-23 |
| Catalog Number | 12247BL |
| Operator | DENTAL HYGIENIST |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL MN 551441000 US 551441000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-08-23 |