MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-10 for CODMAN BACTISEAL HAKIM 82-3072 82-3072 manufactured by Codman & Shurtleff, Inc..
[2006440]
Patient s/p multiple shunt revisions, leaking from skin. Patient returned for catheter malfunction that was implanted ~3 weeks prior. Procedure done for hydrocephalus with shunt malfunction, skin breakdown and contamination with suspected infection. Surgeon notes "there appeared to be a partial proximal catheter blockage with the catheter that was removed. " catheter removed and external ventricular drainage system placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2097233 |
| MDR Report Key | 2097233 |
| Date Received | 2011-05-10 |
| Date of Report | 2011-05-10 |
| Date of Event | 2011-05-05 |
| Report Date | 2011-05-10 |
| Date Reported to FDA | 2011-05-10 |
| Date Added to Maude | 2011-05-20 |
| 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 |
| Brand Name | CODMAN BACTISEAL |
| Generic Name | CATHETER, VENTRICULAR |
| Product Code | HCA |
| Date Received | 2011-05-10 |
| Model Number | HAKIM 82-3072 |
| Catalog Number | 82-3072 |
| Lot Number | CMBBHK |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 50 SCOTLAND PARK DRIVE BRIDGEWATER MA 02324 US 02324 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-05-10 |