MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-12-30 for LUMBAR DRAIN * 10-500 manufactured by Clinical Neuro Systems, Inc..
[176676]
Under fluoroscopy in neuroradiology, a lumber drain catheter fractured while being placed. A small portion of the catheter remained in the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 257491 |
| MDR Report Key | 257491 |
| Date Received | 1999-12-30 |
| Date of Report | 1999-11-30 |
| Date of Event | 1999-11-24 |
| Date Facility Aware | 1999-11-29 |
| Report Date | 1999-11-30 |
| Date Reported to Mfgr | 1999-11-30 |
| Date Added to Maude | 2000-01-07 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | LUMBAR DRAIN |
| Generic Name | MONITOR ICP LUMBAR CATHETER, CLOSED TIP |
| Product Code | MAJ |
| Date Received | 1999-12-30 |
| Model Number | * |
| Catalog Number | 10-500 |
| Lot Number | E99178 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DAY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 249350 |
| Manufacturer | CLINICAL NEURO SYSTEMS, INC. |
| Manufacturer Address | 309 COMMERCE DR. EXTON PA 19341 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1999-12-30 |