MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-11 for CODMAN * manufactured by Codman, Johnson & Johnson.
[314172]
This is the 3rd occurrence of an attending neurosurgeon reporting that a codman perforator failed to stop once the bone had been drilled through. Each event involved a different surgeon. None of the events resulted in harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 559589 |
| MDR Report Key | 559589 |
| Date Received | 2004-05-11 |
| Date of Report | 2004-04-22 |
| Date of Event | 2004-04-14 |
| Date Added to Maude | 2004-12-15 |
| 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 | CODMAN |
| Generic Name | DISPOSABLE PERFORATOR - 14MM |
| Product Code | KAT |
| Date Received | 2004-05-11 |
| Returned To Mfg | 2004-04-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | CW820 |
| ID Number | REF# 26-1221 |
| Device Expiration Date | 2009-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 514936 |
| Manufacturer | CODMAN, JOHNSON & JOHNSON |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US |
| Baseline Brand Name | CODMAN DISPOSABLE PERFORATOR |
| Baseline Generic Name | COMPOUND DRILL |
| Baseline Model No | NA |
| Baseline Catalog No | 26-1221 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-05-11 |