MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-12 for DURAFLOR BUBBLEGUM 5% SODIUM FLOURIDE VARNISH 1033-BG32 manufactured by Medical Products Laboratories, Inc..
[62200937]
Patient had the following reaction to duraflor 1033-bg32: difficulty swallowing, sores on her tongue, headache, sore throat, nausea, swollen lymph nodes, pain in the jaw, burning sensation in the mouth. Did not eat for 4 hours after application of the product. Symptoms continued for 2 days after the initial reaction and started to disappear after 4 days. Her dentist prescribed oracort and she took tylenol extra strength for 5 days (3 tablets per day). History of allergies: balsam of peru.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941138-2016-00015 |
| MDR Report Key | 6168600 |
| Date Received | 2016-12-12 |
| Date of Report | 2016-12-12 |
| Date of Event | 2016-11-17 |
| Date Mfgr Received | 2016-11-24 |
| Date Added to Maude | 2016-12-12 |
| 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 | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH MOORE |
| Manufacturer Street | 13705 SHORELINE COURT EAST |
| Manufacturer City | EARTH CITY MO 63045 |
| Manufacturer Country | US |
| Manufacturer Postal | 63045 |
| Manufacturer Phone | 3143440010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DURAFLOR BUBBLEGUM 5% SODIUM FLOURIDE VARNISH |
| Generic Name | FLOURIDE VARNISH |
| Product Code | LBH |
| Date Received | 2016-12-12 |
| Model Number | 1033-BG32 |
| Lot Number | 50571 |
| Device Expiration Date | 2018-02-28 |
| Operator | DENTAL HYGIENIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL PRODUCTS LABORATORIES, INC. |
| Manufacturer Address | 9990 GLOBAL RD. PHILADELPHIA PA 19115 US 19115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-12 |