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Adverse Event Report

COHESION TECHNOLOGIES, INC. COSEAL SURGICAL SEALANT   back to search results
Model Number FXP070
Event Date 01/01/2004
Event Type  Malfunction   Patient Outcome  Required Intervention;
Event Description

While the scrub nurse was tightening the housing on the syringes prior to mixing, the housing cracked and fluid leaked out of the syringe rendering the kit unusable.

 
Manufacturer Narrative

Surgery was successful with no sealant used. The returned portion of the 2ml coseal was evaluated. The particular part in question, the housing containing the luer locks where the syringes are attached for mixing, was not returned with the rest of the product, and therefore was not available for evaluation. The returned portion, however, was thoroughly evaluated. No abnormalities or defects could be found.

 
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Brand NameCOSEAL SURGICAL SEALANT
Type of DeviceSEALANT
Baseline Brand NameCOSEAL SURGICAL SEALANT
Baseline Generic NameSEALANT
Baseline Catalogue Number934070
Baseline Model NumberFXP070
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
COHESION TECHNOLOGIES, INC.
palo alto CA *
Manufacturer (Section D)
COHESION TECHNOLOGIES, INC.
palo alto CA *
Manufacturer Contact
cecilia kalinowski
2500 faber place
palo alto , CA 94303
(650) 320 -5543
Device Event Key523548
MDR Report Key534278
Event Key507291
Report Number2953731-2004-00001
Device Sequence Number1
Product CodeNBE
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/16/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/16/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date06/01/2004
Device MODEL NumberFXP070
Device Catalogue Number934070
Device LOT NumberC05010021
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer02/18/2004
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/16/2004
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2003
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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