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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFLUENT SPRAYSHIELD POLYMER KIT WITH SPRAYER SPRAYSHIELD KIT

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CONFLUENT SPRAYSHIELD POLYMER KIT WITH SPRAYER SPRAYSHIELD KIT Back to Search Results
Catalog Number SP10S01
Device Problem Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Swelling (2091); Burning Sensation (2146)
Event Date 01/21/2011
Event Type  Injury  
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.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameSPRAYSHIELD POLYMER KIT WITH SPRAYER
Type of DeviceSPRAYSHIELD KIT
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
2034926273
MDR Report Key2037782
MDR Text Key1892332
Report Number3003157248-2011-00007
Device Sequence Number1
Product Code NQR
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility
Reporter Occupation
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 Received03/23/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberSP10S01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/24/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/23/2011 Patient Sequence Number: 1
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