MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-09-15 for CODMAN CATHETER 821706 manufactured by Codman And Shurtleff.
[16050500]
Retained lumbar drain catheter tip requiring retrieval by microsurgical technique. Other than procedure and anesthesia required, no known residual adverse effect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2750740 |
| MDR Report Key | 2750740 |
| Report Source | 99 |
| Date Received | 2008-09-15 |
| Date of Report | 2008-09-12 |
| Date of Event | 2008-09-10 |
| Date Facility Aware | 2008-09-10 |
| Report Date | 2008-09-12 |
| Date Reported to FDA | 2008-09-16 |
| Date Reported to Mfgr | 2008-09-16 |
| Date Added to Maude | 2012-09-21 |
| 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 | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN CATHETER |
| Generic Name | LUMBAR DRAIN CATHETER |
| Product Code | HCA |
| Date Received | 2008-09-15 |
| Model Number | 821706 |
| Catalog Number | 821706 |
| Lot Number | CGCBY4 |
| Device Expiration Date | 2011-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN AND SHURTLEFF |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-09-15 |