MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-04-21 for DARBY VARNISH 9430600 manufactured by Medical Products Laboratories, Inc..
[73450710]
Dental assistant got some of the product on the girl's face and she woke up the next morning with a burn mark on her cheek. The parents of the patient contacted an advise nurse and sent pictures of the burn to her doctor for him to review, along with information about the product. The parents were advised to treat it as a 1st or 2nd degree chemical burn and took the advise steps provided by the doctors. The patient's parents are unaware of any known allergies. The female had received varnish treatments previously. The clinical notes stated that she was treated with varnish preciously on (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941138-2017-00001 |
| MDR Report Key | 6513375 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-04-21 |
| Date of Report | 2017-04-20 |
| Date of Event | 2017-03-24 |
| Date Mfgr Received | 2017-03-27 |
| Device Manufacturer Date | 2016-09-01 |
| Date Added to Maude | 2017-04-21 |
| 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. JACOB FOSTER |
| Manufacturer Street | 13705 SHORELINE COURT EAST |
| Manufacturer City | EARTH CITY MO 63045 |
| Manufacturer Country | US |
| Manufacturer Postal | 63045 |
| Manufacturer Phone | 3143340010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DARBY VARNISH |
| Generic Name | VARNISH |
| Product Code | LBH |
| Date Received | 2017-04-21 |
| Model Number | 9430600 |
| Catalog Number | 9430600 |
| Lot Number | 52123 |
| Device Expiration Date | 2018-09-30 |
| Operator | DENTAL ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL PRODUCTS LABORATORIES, INC. |
| Manufacturer Address | 9990 GLOBAL ROAD PHILADELPHIA PA 19115 US 19115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-21 |