MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-19 for 4916-18 manufactured by Concord/portex.
[18138290]
Portion of epidural catheter remained following removal attempt. Neurosurgeon attempted to surgically remove the foreign body, but was unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25748 |
| MDR Report Key | 25748 |
| Date Received | 1995-01-19 |
| Date of Report | 1995-01-03 |
| Date of Event | 1994-12-29 |
| Date Facility Aware | 1994-12-29 |
| Report Date | 1995-01-03 |
| Date Reported to Mfgr | 1995-01-04 |
| Date Added to Maude | 1995-09-19 |
| 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 |
| 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 |
| Generic Name | EPIDURAL CATHETER |
| Product Code | GZD |
| Date Received | 1995-01-19 |
| Catalog Number | 4916-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 26349 |
| Manufacturer | CONCORD/PORTEX |
| Manufacturer Address | P.O. BOX 724 KEENE NH 034315911 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1995-01-19 |