MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-23 for MI VARNISH 004274 manufactured by Gc Corporation.
[38811613]
Dentist reported that (b)(6) patient received varnish treatment in his office by his hygienist on (b)(6) 2013. Once the varnish was placed the patient's lower lip started to swell in office. The dds did note the patient had a split/cracked lower lip, may have been the entry for the reaction. Dentist confirmed with patient's mother and md that patient does have both a diary and nut allergy, administered 50mg of epinephrine by dentist and had removed the varnish from patient in office. Patient responded well to the epinephrine and is doing well now and shows no lingering signs of reaction. Dentist reported that there was no further injury, or medical intervention needed. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1410097-2016-00002 |
| MDR Report Key | 5454505 |
| Date Received | 2016-02-23 |
| Date of Report | 2016-02-15 |
| Date of Event | 2016-02-13 |
| Date Facility Aware | 2016-02-15 |
| Report Date | 2016-02-19 |
| Date Reported to Mfgr | 2016-02-19 |
| Date Added to Maude | 2016-02-23 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MI VARNISH |
| Generic Name | FLUORIDE VARNISH |
| Product Code | LBH |
| Date Received | 2016-02-23 |
| Returned To Mfg | 2016-02-19 |
| Catalog Number | 004274 |
| Lot Number | 1502242 |
| Device Expiration Date | 2018-02-24 |
| Operator | DENTAL HYGIENIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GC CORPORATION |
| Manufacturer Address | 76-1 HASUNUMA-CHO, ITABASHI-KU TOKYO, 174-8585 JA 174-8585 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-23 |