EMBOSPHERE MICROSPHERES S220GH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2015-02-26 for EMBOSPHERE MICROSPHERES S220GH manufactured by Biosphere Medical, S.a..

Event Text Entries

[5613851] The distributor reported that a fiber/hair was identified in the barrel of the syringe during their 100% inspection of the received products. The device was not sent to a user facility.
Patient Sequence No: 1, Text Type: D, B5


[13122099] Device returned to manufacturer for evaluation. The evaluation is in process. A follow-up report will be submitted when the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9615728-2015-00003
MDR Report Key4638873
Report Source01,07,08
Date Received2015-02-26
Date of Report2015-01-30
Date of Event2014-12-19
Date Mfgr Received2015-01-30
Device Manufacturer Date2014-12-01
Date Added to Maude2015-05-08
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 FDA0
Event Location0
Manufacturer ContactALIX FONLLADOSA
Manufacturer StreetPARC DE NATIONS, PARIS NORD 2 383, RUE DE LA BELLE ETOILE
Manufacturer CityROISSY EN FRANCE CH DE GAULLE CEDE 95 700
Manufacturer CountryFR
Manufacturer Postal95 700
Manufacturer Phone48172529
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEMBOSPHERE MICROSPHERES
Product CodeNAJ
Date Received2015-02-26
Returned To Mfg2015-02-02
Model NumberS220GH
Catalog NumberS220GH
Lot NumberX2723999
Device Expiration Date2017-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBIOSPHERE MEDICAL, S.A.
Manufacturer AddressNORD 2 383 RUE DE LA BELLE ROISSY-EN-FRANCE FR


Patients

Patient NumberTreatmentOutcomeDate
10 2015-02-26

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