MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a unknown report with the FDA on 2015-10-30 for S-11 L G 30057000 manufactured by W & H Dentalwerk Buermoos Gmbh.
[30338302]
During a normal root canal treatment the instrument got hot and the patient suffered a third degree burn on her lips. However, the injury will be presumably reversible and the patient do not require any surgical or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681479-2015-00004 |
| MDR Report Key | 5198219 |
| Report Source | UNKNOWN |
| Date Received | 2015-10-30 |
| Date of Report | 2015-10-30 |
| Date of Event | 2015-10-15 |
| Date Mfgr Received | 2015-10-15 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2015-11-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 53 IGNAZ-GLASER-STRASSE |
| Manufacturer City | BUERMOOS 5111 |
| Manufacturer Country | AU |
| Manufacturer Postal | 5111 |
| Manufacturer Phone | 3627462363 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | S-11 L G |
| Generic Name | SURGICAL HANDPIECE |
| Product Code | KMW |
| Date Received | 2015-10-30 |
| Returned To Mfg | 2015-10-16 |
| Catalog Number | 30057000 |
| Operator | HEALTH PROFESSIONAL |
| 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 | BUERMOOS 5111 AU 5111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-30 |