EMBOSPHERE MICROSPHERES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-19 for EMBOSPHERE MICROSPHERES manufactured by Biosphere Medical Sa.

Event Text Entries

[43016135] No device is expected to be returned for evaluation. Because no unit from the same lot was returned, a formal investigation of the affected device could not be completed and the root cause could not be determined. Since the lot number was not provided, the device history record could not be reviewed. The review of the complaint data base over the last four years did not report any similar adverse event. Device is a permanent implant.
Patient Sequence No: 1, Text Type: N, H10


[43016136] The user reported that after the treatment of a benign prostatic hyperplasia with embolics, the patient developed a full body rash. The rash became desquamating over the next few days and there are multiple erythematous patches remaining several months after the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615728-2016-00001
MDR Report Key5587060
Date Received2016-04-19
Date of Report2016-03-24
Date of Event2016-01-26
Date Mfgr Received2016-03-24
Date Added to Maude2016-04-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS ALIX FONLLADOSA
Manufacturer StreetPARC DES NATIONS-PARIS NORD 2 383, RUE DE LA BELLE ETOILE
Manufacturer CityROISSY- EN- FRANCE, 95700
Manufacturer CountryFR
Manufacturer Postal95700
Manufacturer Phone3314817252
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEMBOSPHERE MICROSPHERES
Generic NameEMBOSPHERE MICROSPHERES
Product CodeNAJ
Date Received2016-04-19
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOSPHERE MEDICAL SA
Manufacturer AddressPARC DES NATIONS-PARIS NORD 2 383, RUE DE LA BELLE ETOILE ROISSY EN FRANCE 95700 US 95700


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-04-19

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