CONFLUENT SPRAYSHIELD MAUDE Adverse Event Report

Oh no! Here we go again! Is it going to be like this? Spraygel
http://ihrt.blogspot.com/2009/02/scarring-caused-by-surgical-gel-spray.html

http://ihrt.blogspot.com/2009/06/surgical-gel-gets-blame-for-pain.html

http://ihrt.blogspot.com/2009/04/covidien-has-ce-mark-for-sprayshieldtm.html

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MAUDE Adverse Event Report
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CONFLUENT SPRAYSHIELD POLYMER KIT WITH SPRAYER CONFLUENT SPRAYSHIELD KIT Back to Search Results

Catalog Number SP10S01
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
(b) (4). (b) (4).


Event Description
Procedure: laparoscopic removal of endometriosis. According to the reporter: the patient presented 24 hours post-operatively with acute abdomen and raised inflammatory markers. There was no bowel or bladder damage and no sepsis. Micro results were negative. The patient was relaparoscopied to check for bowel/bladder damage and none was found.


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Brand Name SPRAYSHIELD POLYMER KIT WITH SPRAYER
Type of Device CONFLUENT SPRAYSHIELD KIT
Manufacturer (Section F) CONFLUENT
101a first avenue
waltham MA 02451

Manufacturer (Section D) CONFLUENT
101a first avenue
waltham MA 02451

Manufacturer (Section G) CONFLUENT
101a first avenue

waltham MA 02451

Manufacturer Contact terry callahan
60 middletown ave.
north haven , CT 06473
(203) 492 -6273

Device Event Key 1709889
MDR Report Key 1668095
Event Key 1584908
Report Number 3003157248-2010-00007
Device Sequence Number 1
Product Code NQR
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 03/08/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 04/19/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number SP10S01
Was Device Available For Evaluation? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 03/08/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown



---Page Last Updated: 08/31/2011
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1668095