MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE

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

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446); Insufficient Information (4580)

Event Date 11/01/2022

Event Type  Injury  

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? which specific ethicon products have been used during the procedures (product code, lot number)? 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.H6 component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2023-06371 and 2210968-2023-06373.Citation: practical hospital clinical journal (november 2022); 19 (6): 119-123.

Event Description

Title: observation of application effect of modified buried vertical mattress suture in preventing poor healing of incision in laparotomy in patients with gynecological malignant tumor.The aim of this study was to investigate the application value of subcutaneous wedge-shaped tension reduction suture (also known as modified buried vertical mattress suture, mbvms) in preventing poor healing of incisions in laparotomy in patients with gynecological malignant tumors.A total of 116 patients who underwent laparotomy for gynecologic malignancy from january 2020 to october 2021 were included in the study.The patients were divided into mbvms or heart-shaped suture group (n=62; mean age of 54.48 ± 10.82 years; mean bmi of 22.26 ± 1.92 kg/m2) and a control group (n=54; mean age of 52.76 ± 7.23 years; mean bmi of 22.34 ± 1.83 kg/m2) according to whether abdominal wound was closed with the mbvms.1-0 absorbable suture (ethicon) was used for peritoneal suture, 2-0 absorbable suture (ethicon) was used for the heart-shaped stitching or intermittent stitching of subcutaneous fat layers, and 3-0 absorbable suture (ethicon) was used for the skin layer.The follow-up was performed every 1 to 2 weeks until 1 month after surgery.Reported complications include incision infection (n=4), incision dehiscence (n=2), fat liquefaction (n=6), and secondary stitching (n=2).In conclusion, the mbvms can effectively reduce the occurrence of poor healing of incision in laparotomy for gynecological malignant tumors.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, 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: 17669624
• MDR Text Key: 322483997
• Report Number: 2210968-2023-06372
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/01/2023
• 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