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

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

Patient Problems Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)

Event Date 08/25/2018

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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: hernia (2018); 22:1045¿1050.Doi: https://doi.Org/10.1007/s10029-018-1811-3.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 the ethicon product (prolene mesh) 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 product involved?.

Event Description

It was reported in a journal article with title: use of polypropylene mesh in contaminated and dirty strangulated hernias: short-term results.The aim of this prospective observational cohort study is to evaluate the outcome of polypropylene mesh in the settings of bowel resection performed for strangulated hernias of the abdominal wall.Between 1st march 2015 and 31st august 2017, a total of 68 hernias required emergency surgery for incarceration; out of these 38 hernias could be reduced without resection of contents.The remaining 30 patients (22 male and 8 female; age range = 25 to 82 years; mean age = 49.9 years) who required resection of gangrenous bowel and anastomosis constituted the study cohort.Surgery was performed using polypropylene mesh (prolene, ethicon).Reported complications included in the group where bowel resection and anastomosis was required were wound infection (n=8) which was managed conservatively with antibiotics and wound dressing by opening a few sutures, draining the collection, and irrigating with hydrogen peroxide and povidone iodine, and all of these wounds healed by secondary intention; seroma (n=10); recurrences (n=2) were observed and both patients had comorbid illness (diabetes and hypertension) and were elderly (> 60 years old).Both patients are on follow-up and have not yet opted for reoperation.In the group where hernias could be reduced, wound infection (n=2) was significantly less not requiring bowel resection; and seroma formation (n=11).In conclusion, the use of polypropylene mesh for contaminated and dirty strangulated hernias is effective and safe, with acceptable morbidity and good short-term results.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11738805
• MDR Text Key: 263574740
• Report Number: 2210968-2021-03922
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention