MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-15 for CODMAN CSF EXTERNAL DRAINAGE SYSTEM 82-1730 2014-03 manufactured by Codman & Shurtleff, Inc.
[2159044]
External ventricular drainage sys fell apart (disconnected) at site of the needless port.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022363 |
| MDR Report Key | 2265563 |
| Date Received | 2011-09-15 |
| Date of Report | 2011-09-15 |
| Date of Event | 2011-09-09 |
| Date Added to Maude | 2011-09-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN CSF EXTERNAL DRAINAGE SYSTEM |
| Generic Name | EXTERNAL VENTRICULAR DRAIN |
| Product Code | HCA |
| Date Received | 2011-09-15 |
| Model Number | 82-1730 |
| Catalog Number | 2014-03 |
| Lot Number | SS3140331CMDCTB+G |
| Device Expiration Date | 2012-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC |
| Manufacturer Address | RAYNHAM MA 02787035 US 02787 0350 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-15 |