MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-05-23 for FLASH LITE MAGNA CR1069 manufactured by Discus Dental, Llc.
[20717901]
(b)(6) stated that after having a routine dental procedure, she had swollen lips and blister caused by a dental curing light. (b)(6) was taken to the emergency room and given motrin.
Patient Sequence No: 1, Text Type: D, B5
[20961406]
At the time the adverse event was reported to discus dental llc on (b)(6) 2014, discus dental no longer manufacture the medical device. The medical device, flashlite magna was divested to denmat in june 2012. All device history records were also given to denmat as part of the divesture. Discus dental have contacted denmat for a copy of the device history record for the medical device evaluation but denmat has not responded as of 03/10/2014.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000582314-2014-00003 |
| MDR Report Key | 3830481 |
| Report Source | 00 |
| Date Received | 2014-05-23 |
| Date of Report | 2014-03-10 |
| Date of Event | 2012-01-26 |
| Date Mfgr Received | 2014-02-20 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2014-05-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1700 A SOUTH BAKER AVE. |
| Manufacturer City | ONTARIO CA 91761 |
| Manufacturer Country | US |
| Manufacturer Postal | 91761 |
| Manufacturer Phone | 9095703512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLASH LITE MAGNA |
| Generic Name | DENTAL CURLING LIGHT |
| Product Code | EBZ |
| Date Received | 2014-05-23 |
| Model Number | MAGNA |
| Catalog Number | CR1069 |
| Lot Number | 11353040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DISCUS DENTAL, LLC |
| Manufacturer Address | ONTARIO CA 91761 US 91761 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-23 |