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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: zhonghua wai ke za zhi.2018 jan 1;56(1):52-55.Doi: 10.3760/cma.J.Issn.0529-5815.2018.01.012.

Event Description

It was reported in a journal article with title: excision of giant desmoid in the abdominal wall, method of abdominal wall reconstruction , and follow-up of long-termed effect.This retrospective study aims to explore the ideal procedure of excision and repair for giant desmoid in the abdominal wall and long-termed follow-up results.From october 2006 to october 2016, 27 patients with giant desmoid tumor of abdominal wall were consecutively approached in our center.24 patients 21 females, aged 16 ¿ 54 years, with an average of 34.6 years; there were 3 males, aged 20 ¿ 79 years, with an average of 42.6 years were recruited.Prosthetic materials: including proceed (johnson & johnson, usa, marketed in china in 2007), composiz-ex (bard, usa, marketed in china in 2006) and pco (kehui, usa, marketed in china in 2008), all of which are anti-adhesion repair materials, were used.Synthetic prosthetic material was used to bridge the defect left after resection.Complete follow-up data were obtained in 22 patients, including 8 outpatients and 14 patients who were followed up by telephone and letter; the follow-up time ranged from 12 to 121 months, with a follow-up time of 63 months.Reported complications included: (n=1) had recent prosthetic material infection after surgery, and recovered with conservative treatment.It was concluded , that the experience of this group of beneficiaries showed that synthetic repair materials can repair large abdominal wall defects or even total anterior wall damage, and have no significant effect on the daily life of the human body after repair.Therefore, we believe that the hard fibers of the abdominal wall should be actively treated with surgery, especially the first operation, and extended resection should be performed actively, and it should be performed carefully according to the key points of surgery.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 08/25/2022.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested and the following was obtained: were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.No.Does the surgeon believe that ethicon product (proceed mesh) involved caused and/or contributed to the post-operative complications described in the article? no.Which specific ethicon products have been used during the procedures (product code, lot number)? code & lot number unknown.Does the surgeon believe there was any deficiency with the ethicon product involved?no.Patient demographics--unknown product complaint #: (b)(4).Date sent to the fda: 08/25/2022.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected information: b1, b2, h1: additional information was received that this device was not involved in the event.Therefore, this medwatch report will be voided.

• Brand Name: PROCEED MESH
• Type of Device: MESH, 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 ; 9083863534
• MDR Report Key: 15274615
• MDR Text Key: 298395257
• Report Number: 2210968-2022-06843
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2022
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other