MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Catalog Number PROMESHUNK

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

Patient Problem Edema (1820)

Event Type  Injury  

Manufacturer Narrative

(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.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 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 used in this procedure? citation: zhongguo zuzhi gongcheng yanjiu.2016;20(25): 3659-3664.(b)(4).

Event Description

It was reported via journal article:"title : the biocompatibility of modified kugel mesh hernia ring filled type tension-free herniorrhaphy" author: wang qing-guang1, wang yan-hong2, zhang cai-kun3, zhang hao-ying3, kong fan-zhong citation: zhongguo zuzhi gongcheng yanjiu.2016;20(25): 3659-3664.This retrospective investigation and analysis aimed to observe the biocompatibility of modified kugel mesh in mesh plug tension-free hernioplasty for inguinal hernia.Between jan2015 to aug2015, a total of 79 patients (n=60 male and n=19 female; average age of 53.21±12.12 years [ranged 20-81 years]) with inguinal hernia underwent tension-free herniorrhaphy which were divided into groups based on the type of mesh: modified kugel mesh (n=38; n=30 male and n=8 female; age of 55.12±10.15 years), and prolene mesh (n=41; n=30 male and n=11 female; age of 52.27±12.37 years).Postoperatively, 2 patients from prolene mesh group developed hydrocele of testes phenomenon, treated with proactive puncture and aspiration therapy.Both patients improved significantly.The outcome indicates that while using different biological mesh to treat inguinal hernia patients through prefix plug tension-free hernioplasty, before and after the treatment, the inflammatory factors of the patients are not increase regardless the application of modified kugel mesh or prolene mesh, and the condition is improved significantly, which indicates the excellent biocompatibility of the two meshes.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8135557
• MDR Text Key: 129437039
• Report Number: 2210968-2018-77545
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PROMESHUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention