MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-29 for VENTRICLEAR G44130 50318 manufactured by Cook Incorporated.
[93221352]
Patient Sequence No: 1, Text Type: N, H10
[93221353]
An external ventricular drain (evd) was placed in a patient on [date redacted]. During removal of the evd one week later, a 0. 5cm portion of the distal tip fractured and was retained. The patient was taken to surgery four days later, and this fragment was retrieved successfully. Manufacturer response for ventricular (per site reporter). Unknown. Pictures were sent to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7066562 |
| MDR Report Key | 7066562 |
| Date Received | 2017-11-29 |
| Date of Report | 2017-11-17 |
| Date of Event | 2017-10-31 |
| Report Date | 2017-11-17 |
| Date Reported to FDA | 2017-11-17 |
| Date Reported to Mfgr | 2017-11-17 |
| Date Added to Maude | 2017-11-29 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTRICLEAR |
| Generic Name | CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS) |
| Product Code | NHC |
| Date Received | 2017-11-29 |
| Model Number | G44130 |
| Catalog Number | 50318 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INCORPORATED |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-29 |