MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-06-01 for DURAFLOR HALO 5% VARNISH 1030-WB32 manufactured by Medical Products Laboratories, Inc..
[76413866]
Product not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[76413867]
The patient had a duraflor halo treatment. Later that day the child experienced fever, pain at stomach, pain at arms, and hallucination. Parent administered tylenol. This was the first time that the patient in question used this product. The patient is allergic to pineapple, dairy, and she is coeliac.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941138-2017-00003 |
| MDR Report Key | 6604490 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-06-01 |
| Date of Report | 2017-05-30 |
| Date of Event | 2017-05-16 |
| Date Mfgr Received | 2017-05-26 |
| Date Added to Maude | 2017-06-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOSE ESPINO |
| 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 | 3 |
| Brand Name | DURAFLOR HALO 5% VARNISH |
| Generic Name | VARNISJ |
| Product Code | LBH |
| Date Received | 2017-06-01 |
| Model Number | 1030-WB32 |
| Catalog Number | 1030-WB32 |
| Lot Number | 53156 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL PRODUCTS LABORATORIES, INC. |
| Manufacturer Address | 9990 GLOBAL ROAD PHILADELPHIS PA 19115 US 19115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-01 |