MAUDE Adverse Event Report: ETHICON INC. MALLA PROLENE LARGE 30X30CM; MESH, SURGICAL, POLYMERIC

Catalog Number PML1

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

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Title: application effect of temporary abdominal closure assisted by negative pressure in abdominal cavity opening with intestinal air fistula.The aim of this study was to investigate the application effect of temporary abdominal closure assisted by negative pressure in abdominal cavity opening with intestinal air fistula.A total of 82 patients with severe abdominal infection caused by intestinal fistula line open in panjin central hospital from february 2019 to february 2020 were included in the study.The patients were divided into control group (n=41; 18 male and 23 female; aged 43.54 ± 7.54 years; bmi 22.14 ± 2.64) and observation group (n=41; 21 male and 20 female; aged 42.64 ± 8.67 years; bmi 22.42 ± 2.53) according to the treatment method.The control group was treated with conventional therapy, main materials: polypropylene mesh pml1 [manufacturer: johnson & johnson medical (shanghai) ltd., 30 cm × 30 cm], silk braided nonabsorbable suture [manufacturer home: johnson & johnson medical (shanghai) ltd., 0# [black].Reported complications include infection (n=4), colonic fistula (n=3), and abdominal hemorrhage (n=5).In conclusion, in patients with severe abdominal infection caused by intestinal fistula line open, negative pressure assisted temporary abdominal closure can effectively shorten the skin grafting time, abdominal wall reconstruction time and total hospital stay, and effectively reduce the probability of complications, which is worthy of popularization and application.

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the death of the patients described in the article? does the surgeon believe that any of the 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 any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? what surgical or medical intervention has been performed? 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.Component code: (b)(4) device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-04536.Citation: medical innovation of china (january 2022);19(2).Https://doi.Org/10.3969/j.Issn.1674-4985.2022.02.035.

Manufacturer Narrative

(b)(4).Date sent to the fda: 6/29/2022.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 inc 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.The following information was requested but unavailable: does the surgeon believe that any of the ethicon products involved caused and/or contributed to the death of the patients described in the article? does the surgeon believe that any of the 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 any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics?.

• Brand Name: MALLA PROLENE LARGE 30X30CM
• 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; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14688006
• MDR Text Key: 294933951
• Report Number: 2210968-2022-04535
• 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,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PML1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2022
• 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