MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-12-21 for VALO CORDLESS BATTERY CHARGING UNIT 5962 manufactured by .
[95958670]
Patient Sequence No: 1, Text Type: N, H10
[95959131]
An email was received on (b)(6) 2017 from a dentist in (b)(6) in regards to a fire that occured a month prior (exact date unknown at this time) at a naval dental clinic in (b)(6). The dentist was asking what we could tell him about a fire that may have occured due to a valo battery charger over heating. After a review of the complaint data base and employee interviews we determined we had no prior knowledge of this event and a call was placed to the facility were we were told it occured. The person at the clinic informed our government accounts manager that he did not have all the information and would call our complaints department. Our customer satisfaction manager did make contact with the two people involved with the fire investigation, the following is known at this time:+? The fire started at 2:00 am on (b)(6) in the (b)(6) clinic. These are old navy buildings with old wiring. ? The source of the fire was definitely from the area of the battery charger in an additional room in the clinic. ? An assistant plugged two battery charging units into the same wall outlet and sat the chargers on a metal table. ? It was burned inside the wall by the battery charger. ? The clinic has over 100 chargers with batteries. They charge 1-3 hours every 2 wks. As of september 09, 2017 nobody from the clinic involved has made contact. Phone call to facility on september 12th 2017- they were not authorized to give us any information. If further information is obtained mdr will be updated if needed. Filing an mdr out of an abundance of caution in the event valo was involved
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718912-2017-00044 |
| MDR Report Key | 7139680 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-21 |
| Date of Event | 2017-07-28 |
| Date Mfgr Received | 2017-08-28 |
| Date Added to Maude | 2017-12-21 |
| 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 Street | 505 W ULTRADENT DRIVE |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8015534500 |
| Manufacturer G1 | ULTRADENT PRODUCTS, INC. |
| Manufacturer Street | 505 W ULTRADENT DRIVE |
| 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 BATTERY CHARGING UNIT |
| Generic Name | VALO CORDLESS BATTERY CHARGING UNIT |
| Product Code | EBZ |
| Date Received | 2017-12-21 |
| Model Number | 5962 |
| Catalog Number | 5962 |
| Lot Number | UNABLE TO OBTAIN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-21 |