MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for HERMETIC VENTRICULAR CATHETER SET INS-4500 manufactured by Integra Lifesciences Corporation.
[183898550]
With the removal of the ventriculostomy, the catheter broke and the distal 3cm of catheter was retained subcutaneously.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9847507 |
| MDR Report Key | 9847507 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-09-17 |
| Report Date | 2020-01-14 |
| Date Reported to FDA | 2020-01-14 |
| Date Reported to Mfgr | 2020-03-18 |
| Date Added to Maude | 2020-03-18 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | HERMETIC VENTRICULAR CATHETER SET |
| Generic Name | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS |
| Product Code | JXG |
| Date Received | 2020-03-18 |
| Model Number | INS-4500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 1100 CAMPUS RD PRINCETON NJ 08540 US 08540 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |