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Adverse Event Report

ETHICON INC 6-0 PROLENE SUTURE   back to search results
Event Date 07/16/1995
Patient Outcome  Death;
Event Description

Plaintiff's estate alleges that prolene suture used for repair of a left carotid endarterectomy on 7/6/95 failed causing plaintiff to die. Further alleges that suture was in a defective condition and unreasonably dangerous when it was supplied or sold to or used on plaintiff causing serious bodily injuries and death when used.

 
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Brand Name6-0 PROLENE SUTURE
Type of DeviceSUTURE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ETHICON INC
u.s. route #22 west
somerville NJ 08876
Manufacturer (Section D)
ETHICON INC
u.s. route #22 west
somerville NJ 08876
Device Event Key101909
MDR Report Key103578
Event Key97394
Report Number103578
Device Sequence Number1
Product CodeGAW
Report Source Distributor
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 07/08/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/08/1997
Distributor Facility Aware Date07/01/1997
Event Location Hospital
Date Report TO Manufacturer07/08/1997
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on February 28, 2009

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