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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 Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Hernia (2240); Weight Changes (2607); Fibrosis (3167); Decreased Appetite (4569)
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. Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2012. Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2013. Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2016. Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2018.
 
Event Description
It was reported by an attorney that the patient underwent recurrent hernia repair surgery on (b)(6) 2012 and mesh was implanted during which the surgeon noted a defect was noted in the inferior/lateral aspect where the mesh was not adhered to the abdominal wall. It was reported that the patient underwent revision surgery on (b)(6) 2012 during which the surgeon noted the mesh was palpated inferiorly and seemed to have pulled away in this area. It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2013 and mesh was implanted during which the surgeon noted we did encounter a couple different layers of mesh in this area. It was inferiorly again where this appeared to have pulled free. Anteriorly, the mesh was identified as a thickened very fibrotic mass. Eventually during the procedure, we ended up removing pretty much all of this in its entirety. It was reported that the patient underwent removal surgery on (b)(6) 2016 during which the surgeon noted the mesh was identified in the lower abdomen and there was bowel adherent to the mesh and the pro-tak coils. A lysis of adhesions was done circumferentially to free the bowel from the mesh. The mesh and all foreign material was removed from the abdomen. It was reported that the patient underwent removal surgery on (b)(6) 2018. It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss. It was reported that the patient had hernia repair surgery on (b)(6) 2011 and mesh was implanted. It was reported that the patient had hernia repair surgery on (b)(6) 2011 and mesh was implanted. Other procedure is captured under separate file. 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 Key13866339
MDR Text Key291482256
Report Number2210968-2022-02071
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 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2013
Device Model NumberPCDG1
Device Catalogue NumberPCDG1
Device Lot NumberEAG013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2012
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: 03/23/2022 Patient Sequence Number: 1
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