CONFLUENT SPRAYSHIELD MAUDE Adverse Event Report

Another one!

CONFLUENT SPRAYSHIELD POLYMER KIT WITH SPRAYER SPRAYSHIELD KIT
Catalog Number SP10S01
Event Date 01/21/2011
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
(b)(4).


Event Description
According to the reporter: the pt experienced heavy underbelly pains two days post-operatively. The pains were described as burning. At the fourth post-operative day, the stomach had to be re-opened. There were syrinxes that were discovered where the product had been applied, which were operated upon. The pt was released from the hospital free of pain.


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

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

Manufacturer (Section G) CONFLUENT
101a first ave.

waltham MA 02451

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

Device Event Key 2070451
MDR Report Key 2037782
Event Key 1934758
Report Number 3003157248-2011-00007
Device Sequence Number 1
Product Code NQR
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/24/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 03/23/2011
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
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 01/24/2011
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


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2037782