MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-01 for DENTAL EZ manufactured by Dental Ez.
[37436871]
Pt was seated in the dental chair when the simplicity dental light on the dental ez chair exploded causing the lights shield to shatter and parts of the light to fall onto the pt. Pt was wearing safety glasses as part of the doctors normal procedure. Pt then rinsed out mouth to make sure nothing had fallen into his mouth and debris was brushed off of him.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059965 |
| MDR Report Key | 5409517 |
| Date Received | 2016-02-01 |
| Date of Report | 2016-02-01 |
| Date of Event | 2016-01-29 |
| Date Added to Maude | 2016-02-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTAL EZ |
| Generic Name | DENTAL CHAIR |
| Product Code | EAZ |
| Date Received | 2016-02-01 |
| Model Number | DENTAL EZ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTAL EZ |
| Manufacturer Address | BAY MINETTE AL 36507 US 36507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-01 |