MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-01-15 for VALO CORDLESS CURING LIGHT 5941 manufactured by Ultradent Products Inc..
[97767504]
Refiling due to original report not being successfully uploaded to data base.
Patient Sequence No: 1, Text Type: N, H10
[97767505]
Pressure built up inside wandbody of the valo unit and batteries blew out of wand causing back cap to break into pieces. The office was closed the day it happened , no injuries were involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718912-2017-00037 |
| MDR Report Key | 7191421 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-01-15 |
| Date of Report | 2017-12-19 |
| Date of Event | 2014-07-08 |
| Date Mfgr Received | 2014-07-08 |
| Device Manufacturer Date | 2012-07-26 |
| Date Added to Maude | 2018-01-15 |
| 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 | 8015525512 |
| 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALO CORDLESS CURING LIGHT |
| Generic Name | DENTAL CURING LIGHT |
| Product Code | EBZ |
| Date Received | 2018-01-15 |
| Returned To Mfg | 2014-07-14 |
| Model Number | 5941 |
| Catalog Number | 5941 |
| Lot Number | B7BJF |
| 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 | SOUTH JORDAN UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-15 |