MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-02 for EMBOZENE? MICROSPHERES 01-0301-04002-07 14020-S1 manufactured by Boston Scientific - Cork.
[112995776]
Device evaluated by mfr: 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
[112995777]
It was reported that the patient experienced headaches and claudication. The patient underwent an embolization of the right and left internal maxillary arteries using 400um embozene? Microspheres in (b)(6) 2018. In (b)(6) 2018, the patient developed headaches on bilateral hemicrania predominantly on the left side, claudication of the jaw, and induration of the temporal right artery with hyperesthesia of bilateral scalp. The physician prescribed corticotherapy of 0. 7mg / kg for one month allowing a regression of all symptoms. Ten days after discontinuation of corticosteroids the headaches reappeared.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-05873 |
| MDR Report Key | 7655912 |
| Date Received | 2018-07-02 |
| Date of Report | 2018-06-07 |
| Date of Event | 2018-04-01 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2017-09-20 |
| Date Added to Maude | 2018-07-02 |
| 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 |
| Manufacturer G1 | BOSTON SCIENTIFIC - CORK |
| Manufacturer Street | BUSINESS AND TECHNOLOGY PARK MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EMBOZENE? MICROSPHERES |
| Generic Name | AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS |
| Product Code | NAJ |
| Date Received | 2018-07-02 |
| Model Number | 01-0301-04002-07 |
| Catalog Number | 14020-S1 |
| Lot Number | 21148118 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - CORK |
| Manufacturer Address | BUSINESS AND TECHNOLOGY PARK MODEL FARM ROAD CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-07-02 |