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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED MESH MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PROCEEDMUNK
Device Problem No Apparent Adverse Event (3189)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

Product complaint # (b)(4). This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation: the american surgeon (2014); 80: 489-495. Attempts are being made to obtain the following information.   to date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Does the surgeon believe that ethicon products (proceed mesh, ultrapro mesh, prolene mesh, prolene suture, and pds ii suture) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products involved? (b)(4).

 
Event Description

It was reported in a journal article with title: noncrosslinked porcine-derived acellular dermal matrix for single-stage complex abdominal wall herniorrhaphy after removal of infected synthetic mesh: a retrospective review. The objective of this retrospective case review was to assess outcomes after surgery in patients who had a recurrent, complex incisional hernia associated with previously placed, infected synthetic mesh and underwent single-stage incisional herniorrhaphy using reinforcement with porcine-derived acellular dermal matrix (padm). Between 2009 and 2011, a total of 13 patients (n=5 male and n=8 female; mean age of 60±13 years [ranged 38-79 years]; mean bmi of 35. 6±10. 8 years [ranged 26-65]) with grade 4 infected synthetic mesh underwent single-stage complex abdominal wall herniorrhaphy after removal of infected synthetic mesh. Of the 13 patients, prolene mesh (n=3), prolene mesh + gore-tex (n=1), prolene mesh + ultrapro mesh (n=1) and proceed mesh (n=1) were removed during the surgery. In the operation, herniorrhaphy was performed using #1 prolene or pds sutures, and was also used to secure padm. Blake drains (size 19 french) were placed in all patients, except two who had vacuum-assisted closure placed on an open wound. All patients received antibiotic regimens initiated before surgery and adjusted postoperatively as needed based on culture results. Vancomycin, piperacillin/tazobactam, and ertapenem were the most commonly administered perioperative antibiotics. Postoperative complications included wound infection (n=1) that was drained surgically without removal of the padm, and seroma (n=1) that resolved without intervention. The encouraging results with regard to postoperative infection and recurrence rates seen here and previously for herniorrhaphy with a biologic matrix may be related to the inherent scaffold like properties of biologic matrices, which encourage growth of native tissue into the matrix. Perhaps because biologic matrices permit cellular and vascular infiltration into the prosthesis, greater resistance to and clearance of pathogens versus synthetic mesh may be possible.

 
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Brand NamePROCEED MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8907304
MDR Text Key154774124
Report Number2210968-2019-85754
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 HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 07/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPROCEEDMUNK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2019
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/19/2019 Patient Sequence Number: 1
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