MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-06 for VALO GRAND 5972 manufactured by Ultradent Products, Inc..
[69202484]
Filing out of an abundance of caution due to the fact the valo was used during restorations which later turned out to be the restoration material used and cure times stated on the manufactures restoration material. Dr. Did not want to return light as he indicated the light functioned as intended. No device malfunction reported.
Patient Sequence No: 1, Text Type: N, H10
[69202485]
Doctor has been using activa for about 2 years now, with no issues. Recently had 4 patients develop abscesses associated with small mo/do restorations placed approximately 6 months ago. The only change in protocol within the last six months is the recently purchased curing light. Doctor went from a valo corded to a valo cordless grand. Used the cordless on the fastest (curing) setting due to the fact that speed is key for pediatric patients. Email came in asking if there were any output differences between the corded and the cordless.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718912-2017-00002 |
| MDR Report Key | 6382979 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-06 |
| Date of Report | 2017-03-06 |
| Date of Event | 2017-02-02 |
| Date Mfgr Received | 2017-02-02 |
| Device Manufacturer Date | 2016-06-26 |
| Date Added to Maude | 2017-03-06 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 8015534200 |
| Manufacturer G1 | ULTRADENT PRODUCTS, INC. |
| Manufacturer Street | 505 WEST 10200 SOUTH |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84095 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALO GRAND |
| Generic Name | DENTAL CURING LIGHT |
| Product Code | EBZ |
| Date Received | 2017-03-06 |
| Catalog Number | 5972 |
| Lot Number | BD44B |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2017-03-06 |