MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-03-04 for FHC MICROELECTRODE 44975Z manufactured by Fhc, Inc,.
[137874914]
Procedure - staged bi-lateral dbs procedure. The first surgery was performed (one side of a bi-lateral procedure). The patient was sent home (planned) and was to come back and do the second surgery. Fhc emailed to check on when the second surgery was going to be scheduled and the hospital administrative person said the second surgery was canceled because the patient passed away. The surgeon noted that the surgery went great, the patient was fine after surgery and went home the next day and had a delayed hemorrhage and passed away.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002250546-2019-00002 |
| MDR Report Key | 8388293 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-04 |
| Date of Report | 2019-03-03 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2019-02-25 |
| Date Added to Maude | 2019-03-04 |
| 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. CRAIG PAGAN |
| Manufacturer Street | 1201 MAIN STREET |
| Manufacturer City | BOWDOIN ME 04287 |
| Manufacturer Country | US |
| Manufacturer Postal | 04287 |
| Manufacturer Phone | 2076665651 |
| Manufacturer G1 | FHC, INC, |
| Manufacturer Street | 1201 MAIN STREET |
| Manufacturer City | BOWDOIN ME 04287 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 04287 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FHC MICROELECTRODE |
| Generic Name | DEPTH ELECTRODE |
| Product Code | GZL |
| Date Received | 2019-03-04 |
| Model Number | 44975Z |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FHC, INC, |
| Manufacturer Address | 1201 MAIN STREET BOWDOIN ME 04287 US 04287 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-03-04 |