MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-23 for SMITH & NEWMAN * 70135050 manufactured by *.
[271562]
Shaw handle worked for 1/2 hr then stopped calibrating. A new handle was used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024883 |
| MDR Report Key | 392074 |
| Date Received | 2002-04-23 |
| Date of Report | 2002-04-23 |
| Date of Event | 2002-04-15 |
| Date Added to Maude | 2002-05-08 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | SMITH & NEWMAN |
| Generic Name | HEMOSTATIX THERMAL SCALPEL |
| Product Code | GEJ |
| Date Received | 2002-04-23 |
| Model Number | * |
| Catalog Number | 70135050 |
| Lot Number | 0212548258 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 381103 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-04-23 |