MAUDE Adverse Event Report ~ Abdolift and Spray Gel

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CONFLUCENT SPRAYGEL ADHESION BARRIER SYSTEM Back to Search Results

Model Number PK-A-6010
Event Date 02/07/2003
Event Type Injury Patient Outcome Required Intervention;
Event Description
The pt reported that she had problems with adhesions and pain. She had surgery performed at endogyn in another country, to remove the adhesions. The procedure was performed using a gasless laparoscopy technique with an abdominal wall retractor. The adhesions returned within 2 months of the surgery and after 6 months the adhesions became calcified. The pt claims that the surgery has damaged her internalorgans. She believes that the method of using the abdominal wall retractor with gasless laparoscopy is detrimental to the pt. She subsequently had additional surgery performed in the united states because of problems related to the surgery in another country.


Manufacturer Narrative
Confluent surgical was named as the mfr in medwatch report. The device named in the report is "abdominal wall retractor" Abdolift. Confluent surgical does not mfr, market, or distribute this device. When contacted by confluent, the reporter stated that the confluent product used in the surgery is spraygel. The "abdominal wall retractor", which is mfg by another co, was also used in the surgery. The event did not occur in the united states, it occurred in another country. Spraygel is not marketed or distributed in the united states. The reporter's complaint concerned the method of gasless laparoscopy and the use of the abdominal wall retractor, not the use of spraygel.


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Brand Name SPRAYGEL ADHESION BARRIER SYSTEM
Manufacturer (Section F) CONFLUCENT
boston MA *

Manufacturer (Section D) CONFLUENT SURGICAL INC.
waltham MA *

Manufacturer Contact amita shah
101a first ave
waltham , MA 02451
(781) 839 -1726

Device Event Key 830606
MDR Report Key 878848
Event Key 806304
Report Number 3003157248-2007-00001
Device Sequence Number 1
Product Code MCN
Report Source Manufacturer
Source Type Other
Reporter Occupation Patient
Type of Report Initial
Report Date 05/14/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 06/25/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number PK-A-6010
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received 05/14/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/25/2007 Patient Sequence Number: 1
# Treatment Treatment Date
ABDOMINAL WALL RETRACTOR USED IN GASLESS
2,LAPAROSCOPY


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=878848
---Page Last Updated: 10/31/2011