MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-05-18 for CLARUS MEDICAL * REF1100-002 manufactured by Clarus Medical.
[17424376]
While dr was doing a laser discectomy, the fiber broke, causing a small burn to the physician's arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021928 |
| MDR Report Key | 333883 |
| Date Received | 2001-05-18 |
| Date of Report | 2001-05-17 |
| Date of Event | 2001-05-16 |
| Date Added to Maude | 2001-05-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLARUS MEDICAL |
| Generic Name | ENDOSCOPIC DISSECTOMY KIT |
| Product Code | GDB |
| Date Received | 2001-05-18 |
| Returned To Mfg | 2001-05-17 |
| Model Number | * |
| Catalog Number | REF1100-002 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 323247 |
| Manufacturer | CLARUS MEDICAL |
| Manufacturer Address | 1000 BOONE AVE N MINNEAPOLIS MN 55427 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-05-18 |