MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-22 for CODMAN * manufactured by Codman And Shurtleff, Inc..
[342432]
Malfunction of perforator burr. Bit failed to stop when through the skull. No injury to pt. Finished procedure with different burr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1030648 |
| MDR Report Key | 505571 |
| Date Received | 2003-12-22 |
| Date of Report | 2003-10-22 |
| Date of Event | 2003-10-16 |
| Date Added to Maude | 2004-01-13 |
| 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 | 3 |
| 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 | CODMAN |
| Generic Name | DISPOSABLE PERFORATOR |
| Product Code | HBG |
| Date Received | 2003-12-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | GV822 2008-07 |
| ID Number | REF 26-1221 14MM |
| Device Expiration Date | 2008-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 494441 |
| Manufacturer | CODMAN AND SHURTLEFF, INC. |
| Manufacturer Address | * RAYNHAM MA 027670350 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-12-22 |