ENBOSPHERE MICROSPHERES S420GH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07,08 report with the FDA on 2015-01-14 for ENBOSPHERE MICROSPHERES S420GH manufactured by Biosphere Medical, S.a..

Event Text Entries

[5328754] The distributor reported that a fiber/hair was identified in the barrel of the syringe during their 100% inspection of received product. The device was not sent to a user facility.
Patient Sequence No: 1, Text Type: D, B5


[12907707] Device returned to mfr for eval. The eval is in progress. A f/u report will be submitted when the eval is completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9615728-2015-00001
MDR Report Key4479672
Report Source00,01,07,08
Date Received2015-01-14
Date of Report2014-12-25
Date of Event2014-11-26
Date Mfgr Received2014-12-25
Device Manufacturer Date2014-10-01
Date Added to Maude2015-03-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactALIX FONLLADOSA
Manufacturer Street383, RUE DE LA BELLE ETOILE PARC DES NATIONS - PARIS NORD 2
Manufacturer CityROISSY EN FRANCE 95 700
Manufacturer CountryFR
Manufacturer Postal95 700
Manufacturer Phone4817252
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENBOSPHERE MICROSPHERES
Generic NameAGENTS, EMBOLIC, FOR TREATMENT OF UF
Product CodeNAJ
Date Received2015-01-14
Returned To Mfg2014-12-30
Model NumberS420GH
Catalog NumberS420GH
Lot NumberX700013
Device Expiration Date2017-09-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBIOSPHERE MEDICAL, S.A.
Manufacturer AddressROISSY-EN-FRANCE FR


Patients

Patient NumberTreatmentOutcomeDate
10 2015-01-14

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