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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
Model Number PCDG1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fistula (1862); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2009 and mesh was implanted. It was reported that the patient underwent removal and revision surgery on (b)(6) 2019 during which the surgeon noted dense phlegmon to midline abdominal wall consisting of mesh with enterocutaneous fistula and adherent loop of small bowel. He performed a small bowel resection, lysis of adhesions and explanted the mesh. It was reported that the patient experienced enterocutaneous fistula, dense small bowel adhesions, severe abdominal pain and discomfort. No additional information was provided.
 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-CORNELIA
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12849845
MDR Text Key285562468
Report Number2210968-2021-11792
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2011
Device Model NumberPCDG1
Device Catalogue NumberPCDG1
Device Lot NumberBLG541
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2009
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: 11/21/2021 Patient Sequence Number: 1
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