MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-01 for S-12 30061000 manufactured by W&h Dentalwerk Buermoos Gmbh.
[134705171]
The handpiece was analysed in w&h service station. There were no damages identified. It functions accordingly during the test procedure.
Patient Sequence No: 1, Text Type: N, H10
[134705172]
The end-user stated that the tip of the handpiece s-12 got hot and burned the patient. Also the assistant got burn marks after touching the handpiece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681479-2019-00001 |
| MDR Report Key | 8295675 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-01 |
| Date of Report | 2019-01-22 |
| Date of Event | 2019-01-04 |
| Date Mfgr Received | 2019-01-22 |
| Date Added to Maude | 2019-02-01 |
| 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 | ANJA DUERAGER |
| Manufacturer Street | IGNAZ-GLASER-STRASSE 53 |
| Manufacturer City | BUERMOOS, SALZBURG 5111 |
| Manufacturer Country | AU |
| Manufacturer Postal | 5111 |
| Manufacturer G1 | W&H DENTALWERK BUERMOOS GMBH |
| Manufacturer Street | IGNAZ-GLASER-STRASSE 53 |
| Manufacturer City | BUERMOOS, SALZBURG 5111 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 5111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S-12 |
| Generic Name | SURGICAL HANDPIECE |
| Product Code | KMW |
| Date Received | 2019-02-01 |
| Model Number | S-12 |
| Catalog Number | 30061000 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W&H DENTALWERK BUERMOOS GMBH |
| Manufacturer Address | IGNAZ-GLASER-STRASSE 53 BUERMOOS, SALZBURG 5111 AU 5111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-01 |