MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-12 for HUMMINGBIRD VENTRICULAR H200MR manufactured by Innerspace Inc..
[24981007]
During placement of the ventriculostomy catheter the first catheter inserted unfortunately was fractured or lacerated by the inner table and a fragment of catheter was left in situ.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5048851 |
| MDR Report Key | 5048851 |
| Date Received | 2015-08-12 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-08-01 |
| Date Facility Aware | 2015-08-01 |
| Report Date | 2015-08-11 |
| Date Reported to FDA | 2015-08-11 |
| Date Reported to Mfgr | 2015-08-11 |
| Date Added to Maude | 2015-09-02 |
| 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 | 0 |
| Brand Name | HUMMINGBIRD VENTRICULAR |
| Generic Name | VENTRICULAR CATHETER |
| Product Code | HCA |
| Date Received | 2015-08-12 |
| Model Number | H200MR |
| Lot Number | 140616-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNERSPACE INC. |
| Manufacturer Address | 1622 EDINGER AVE. STE C TUSTIN CA 92780 US 92780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-08-12 |