EMBOZENE? MICROSPHERES 01-0301-05002-04 15020-S1

MAUDE Adverse Event Report

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 01-0301-05002-04 15020-S1 manufactured by Boston Scientific - Maple Grove.

Event Text Entries

[116358483] Event date: approximately (b)(6) 2018. Device evaluated by manufacturer: 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


[116358484] Same case as mdr id# 2134265-2018-06928. It was reported that the patient experienced an infection. The patient was treated with 500 & 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


MAUDE Entry Details

Report Number2134265-2018-06927
MDR Report Key7760255
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-08-07
Date of Report2018-07-12
Date Mfgr Received2018-07-12
Date Added to Maude2018-08-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactEMP. SONALI ARANGIL
Manufacturer StreetONE SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634941700
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEMBOZENE? MICROSPHERES
Generic NameEMBOLIC DEVICE
Product CodeNAJ
Date Received2018-08-07
Model Number01-0301-05002-04
Catalog Number15020-S1
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - MAPLE GROVE
Manufacturer AddressONE SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-08-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.