MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Hernia (2240)

Event Date 04/08/2022

Event Type  Injury  

Event Description

Title: application efficacy of multidimensional suture technique in laparoscopic repair of giant incisional hernia.The objective of this study is to demonstrate the clinical value of multidimensional suture technique in giant incision hernia repair by comparing its clinical efficacy with that of conventional suture technique in laparoscopic repair of large incisional hernia.The data of patients with giant incisional hernia who underwent laparoscopic intraperitoneal onlay mesh repair for giant incision hernia in the department of gastrointestinal and hernia surgery, the sixth affiliated hospital of (b)(6) university from (b)(6) 2018 to (b)(6) 2020 were retrospectively analyzed.Of the patients, 43 cases received "multidimensional suture" for the treatment of hernia sac and defect (study group), and 36 cases underwent the conventional suture method for the closure of defect (control group).(poly-p-dioxanone, ppdo; johnson & johnson) was used.Reported complications included surgical site infection (n=3), subcutaneous exudate (n=2), postoperative recurrence (n=?).In conclusion the application of multidimensional suture technique in giant incision hernia repair can decrease the conversion rate to open surgery, effectively close the fascia defect, and reduce the risk of postoperative surgical site occurrence.

Manufacturer Narrative

(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 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.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 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? 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).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: chinese journal of general surgery, 2022, 31 (4): 465-473.Doi:10.7659/j.Issn.1005-6947.2022.04.008.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 14936030
• MDR Text Key: 295404356
• Report Number: 2210968-2022-05136
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2022
• 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): Required Intervention