MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-05-11 for VENTRICLEAR DRAINAGE CATHETER SET N/A 50318 manufactured by Cook Inc.
[74909533]
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[74909534]
A representative of a spinal and orthopedic device manufacturer reported that a physician stated the ventriclear drainage catheter broke off during an unspecified procedure during insertion. Additional information was requested regarding retrieval of the device and patient outcome; however, at this time no further information is available from the initial reporter. The contact information for the reporting physician, including user facility information is not available. A statement that this event occurred multiple times cannot be validated. There is no further information available and the device is not available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-01018 |
| MDR Report Key | 6559714 |
| Report Source | OTHER |
| Date Received | 2017-05-11 |
| Date of Report | 2017-08-29 |
| Date Mfgr Received | 2017-08-03 |
| Device Manufacturer Date | 2016-05-31 |
| Date Added to Maude | 2017-05-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTRICLEAR DRAINAGE CATHETER SET |
| Generic Name | NHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC 0R ANTIMICROBIAL AGENTS) |
| Product Code | NHC |
| Date Received | 2017-05-11 |
| Model Number | N/A |
| Catalog Number | 50318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-11 |