MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-24 for CAVITRON SELECT SPS ULTRASONIC SCALER G124 81324 manufactured by Dentsply Llc.
[186735508]
While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr part 803. Water filter build up/debris.
Patient Sequence No: 1, Text Type: N, H10
[186735509]
While using a g124 scaler, the tip and water were overheating; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2424472-2020-00027 |
| MDR Report Key | 9875233 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-20 |
| Date Added to Maude | 2020-03-24 |
| 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 | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 8494229 |
| Manufacturer G1 | DENTSPLY LLC |
| Manufacturer Street | 1301 SMILE WAY |
| Manufacturer City | YORK, PA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAVITRON SELECT SPS ULTRASONIC SCALER |
| Generic Name | SCALER, ULTRASONIC |
| Product Code | ELC |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2020-02-26 |
| Model Number | G124 |
| Catalog Number | 81324 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY LLC |
| Manufacturer Address | 1301 SMILE WAY YORK, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |