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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSPHERE MEDICAL, S.A. ENBOSPHERE MICROSPHERES; AGENTS, EMBOLIC, FOR TREATMENT OF UF
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BIOSPHERE MEDICAL, S.A. ENBOSPHERE MICROSPHERES; AGENTS, EMBOLIC, FOR TREATMENT OF UF Back to Search Results
Model Number S420GH
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2014
Event Type  malfunction  
Event Description
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.
 
Manufacturer Narrative
Device returned to mfr for eval.The eval is in progress.A f/u report will be submitted when the eval is completed.
 
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Brand Name
ENBOSPHERE MICROSPHERES
Type of Device
AGENTS, EMBOLIC, FOR TREATMENT OF UF
Manufacturer (Section D)
BIOSPHERE MEDICAL, S.A.
roissy-en-france
FR 
Manufacturer Contact
alix fonlladosa
383, rue de la belle etoile
parc des nations - paris nord 2
roissy en france 95 70-0
FR   95 700
4817252
MDR Report Key4479672
MDR Text Key5328754
Report Number9615728-2015-00001
Device Sequence Number1
Product Code NAJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K021397
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2017
Device Model NumberS420GH
Device Catalogue NumberS420GH
Device Lot NumberX700013
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/30/2014
Date Manufacturer Received12/25/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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