MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-09-19 for CUTTING ELECTRODE 8416.0305 manufactured by Richard Wolf Medical Instruments Corp..
| Report Number | 1418479-2019-00050 |
| MDR Report Key | 9090336 |
| Report Source | USER FACILITY |
| Date Received | 2019-09-19 |
| Date of Report | 2019-08-29 |
| Date Mfgr Received | 2019-08-19 |
| Date Added to Maude | 2019-09-19 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DAISY RAMOS |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 600613110 |
| Manufacturer Country | US |
| Manufacturer Postal | 600613110 |
| Manufacturer Phone | 8479131113 |
| Manufacturer G1 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 600613110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600613110 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUTTING ELECTRODE |
| Generic Name | CUTTING ELECTRODE |
| Product Code | FAS |
| Date Received | 2019-09-19 |
| Model Number | 8416.0305 |
| Catalog Number | 8416.0305 |
| Lot Number | 1390827 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Address | 353 CORPORATE WOODS PARKWAY VERNON HILLS IL 600613110 US 600613110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-19 |