MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-29 for VALO CURING LIGHT 5919 manufactured by Ultradent Products Inc..
[6046092]
Dds alleged that two patients were burned on the outside of the cheek from the valo curing light while curing sealants on tooth #19. Neosporin was used. This is the first of the two reports.
Patient Sequence No: 1, Text Type: D, B5
[13703459]
After extensive testing on the unit returned concluded the unit did not get hot enough to create a burn under normal use, but because intervention was performed by applying neosporin to the affected area this event is reportable as per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718912-2015-00002 |
| MDR Report Key | 4874814 |
| Report Source | 05 |
| Date Received | 2015-06-29 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-02-16 |
| Date Mfgr Received | 2015-04-06 |
| Device Manufacturer Date | 2015-04-19 |
| Date Added to Maude | 2015-06-29 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS RONA MURPHY |
| Manufacturer Street | 505 WEST 10200 SOUTH |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8005525512 |
| Manufacturer G1 | ULTRADENT PRODUCTS |
| Manufacturer Street | 505 WEST 10200 SOUTH |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84095 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALO CURING LIGHT |
| Generic Name | COMPOSITE CURING LIGHT |
| Product Code | EBZ |
| Date Received | 2015-06-29 |
| Returned To Mfg | 2015-04-27 |
| Model Number | 5919 |
| Catalog Number | 5919 |
| Lot Number | B5YLG |
| Operator | DENTIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS INC. |
| Manufacturer Address | 505 WEST 10200 SOUTH SOUTH JORDAN UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-29 |