MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-03 for PERFORATOR * manufactured by Codman And Shurtleff, Inc..
[340358]
The perforator did not stop once the burr hole was accomplished. It perforated the dura but not the brain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 500469 |
| MDR Report Key | 500469 |
| Date Received | 2003-12-03 |
| Date of Report | 2003-09-01 |
| Date of Event | 2003-08-01 |
| Date Added to Maude | 2003-12-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERFORATOR |
| Generic Name | PERFORATOR |
| Product Code | KAT |
| Date Received | 2003-12-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 489237 |
| Manufacturer | CODMAN AND SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-12-03 |