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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PCDG1
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Vomiting (2144); Discomfort (2330); Fibrosis (3167)
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2015. Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2015. Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2015. Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2016.

 
Event Description

It was reported by an attorney that the patient underwent ventral hernia repair surgery on (b)(6) 2007 and mesh was implanted. It was reported that the patient underwent laparoscopic sleeve gastrectomy on (b)(6) 2015 during which the surgeon noted numerous adhesions of omentum to the anterior wall and to the mesh. He performed extensive lysis of adhesions. It was reported that the patient underwent laparoscopic enterolysis on (b)(6) 2015 during which the surgeon noted multiple adhesions of the omentum to the anterior abdominal wall and adhesions of a loop of bowel to the upper third of the mesh, creating a kinking effect. It was noted that a piece of the mesh was stuck to the small bowel. This piece of mesh was separated from the small bowel and explanted. It was reported that the patient underwent diagnostic laparoscopy on (b)(6) 2015 during which the surgeon noted that the small bowel was so severely adherent to the mesh and indurated, requiring resection. The surgeon also noted kinking in the bowel and dense intra-loop adhesions. He explanted to remaining portion of the mesh. It was reported that the patient underwent exploratory laparotomy due to closed loop bowel obstruction on (b)(6) 2016 during which the surgeon noted gangrenous small bowel, multiple inter-loop bowel adhesions, multiple abdominal adhesions and thick scarring. The surgeon performed lysis of adhesions and a small bowel resection. It was reported that the patient underwent ventral hernia repair surgery on (b)(6) 2016. It was reported that the patient experienced recurrent small bowel obstructions, gangrenous bowel, fibrosis fat necrosis, foreign body granulomatous reaction to the mesh, fibrosis, scarring, acute chronic inflammation, abdominal pain and discomfort, nausea and vomiting. No additional information is provided.

 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-CORNELIA
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key9860892
MDR Text Key193064066
Report Number2210968-2020-02066
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2008
Device Catalogue NumberPCDG1
Device LOT NumberZHG454
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/02/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/20/2020 Patient Sequence Number: 1
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