MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-08-07 for EMBOZENE? MICROSPHERES 01-0301-07002-04 17020-S1 manufactured by Boston Scientific - Maple Grove.
[116356552]
Approximately (b)(6) 2018. It is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[116356553]
Same case as mdr id# 2134265-2018-06927. It was reported that the patient experienced an infection. The patient was treated with 500 and 700 microns of embozene microspheres for a uterine fibroids embolization. The patient presented to the er a week later with an extremely bad infection and the white count over 20,000 after being treated. No further patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-06928 |
| MDR Report Key | 7760258 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-07 |
| Date of Report | 2018-07-12 |
| Date Mfgr Received | 2018-07-12 |
| Date Added to Maude | 2018-08-07 |
| 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 | EMP. SONALI ARANGIL |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOZENE? MICROSPHERES |
| Generic Name | EMBOLIC DEVICE |
| Product Code | NAJ |
| Date Received | 2018-08-07 |
| Model Number | 01-0301-07002-04 |
| Catalog Number | 17020-S1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MAPLE GROVE |
| Manufacturer Address | ONE SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-07 |