MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-16 for S-12 SURGICAL HANDPIECE 30061000 manufactured by W&h Dentalwerk Buermoos Gmbh.
[142037547]
During a dental surgica treatment the instrument got hot and it ended up in burning the patient's lip (2nd degree). The injury is reversible and the patient is under monitoring. After evaluation of the suspect device it came out that the adverse event occured due to wrong lubrication of the instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681479-2019-00002 |
| MDR Report Key | 8517118 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-16 |
| Date of Report | 2019-03-18 |
| Date of Event | 2019-03-15 |
| Date Mfgr Received | 2019-03-18 |
| Device Manufacturer Date | 2018-09-27 |
| Date Added to Maude | 2019-04-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 LINDNER |
| 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 | 2019-04-16 |
| Model Number | SURGICAL HANDPIECE |
| 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 | 1. Hospitalization | 2019-04-16 |