MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-28 for COLTENE/WHALEDENT INC. BIOSONIC ULTRASONIC CLEANER UC95 manufactured by Coltene/whaledent Inc..
[41637123]
Office personnel walked into the room and observed the unit already emitting a blue flame. No smoke was observed (but this may have occurred prior to the blue flame). Incident occurred around mid day during a standard cleaning cycle, perhaps the second cycle of the day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2416455-2016-03002 |
| MDR Report Key | 5529138 |
| Date Received | 2016-03-28 |
| Date of Report | 2016-03-28 |
| Date of Event | 2016-02-25 |
| Date Facility Aware | 2016-02-25 |
| Report Date | 2016-02-26 |
| Date Reported to Mfgr | 2016-02-26 |
| Date Mfgr Received | 2016-03-01 |
| Date Added to Maude | 2016-03-28 |
| 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 | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRUCE KUCHARSKI |
| Manufacturer Street | 235 ASCOT PARKWAY |
| Manufacturer City | CUYAHOGA FALLS OH 44223 |
| Manufacturer Country | US |
| Manufacturer Postal | 44223 |
| Manufacturer Phone | 3309168932 |
| Manufacturer G1 | COLTENE/WHALEDENT INC |
| Manufacturer Street | 235 ASCOT PARKWAY |
| Manufacturer City | CUYAHOGA FALLS OH 44223 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44223 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COLTENE/WHALEDENT INC. |
| Generic Name | UC 95 ULTRASONIC CLEANER |
| Product Code | FLG |
| Date Received | 2016-03-28 |
| Returned To Mfg | 2016-03-10 |
| Model Number | BIOSONIC ULTRASONIC CLEANER |
| Catalog Number | UC95 |
| Device Availability | R |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLTENE/WHALEDENT INC. |
| Manufacturer Address | 235 ASCOT PARKWAY CUYAHOGA FALLS OH 44223 US 44223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-28 |