| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 3M ESPE CLINPRO WHITE VARNISH | CAVITY VARNISH | 3M ESPE DENTAL PRODUCTS | LBH | 12247BL | R | * |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-08-23 | 0 | 1. H |
Patient 1
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 1
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.