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

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

Patient Problems Unspecified Infection (1930); Impaired Healing (2378); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 08/22/2022

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.As no contact information has been provided, no follow up can or will be performed at this time.Should further details be provided, the file will be updated accordingly.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 2210968-2024-00485.Citation: chinese journal of modern operative surgery, aug.2022,vol.26, no.4; 294-303.

Event Description

Title: evaluation of effects of subcutaneous heart-shaped cosmetic suture in primary caesarean section.The aim of this study was to evaluate the effect of subcutaneous heart-shaped cosmetic suture on postoperative scar after caesarean sections.A total of 358 patients who underwent caesarean sections from december 2020 to april 2022 were included in the study.They were divided into two groups with 180 patients of the heart-shaped group and 178 patients in the control group.The control group was stitched with conventional discontinuous suture method using 2-0 absorbable suture (unknown manufacturer) was used for subcutaneous non-tension-relieving interrupted suture, and the heart-shaped group was stitched with johnson & johnson control release 2-0 absorbable suture for subcutaneous heart-shaped tension-reducing cosmetic suture.In both group, a 4-0 absorbable vicryl suture was used for intradermal continuous suture of dermis.Reported complications in the heart-shaped group include incision swelling (n=3), incision infection (n=1), fat liquefaction (n=2), and grade b wound healing condition (n=5).In the control group includes incision swelling (n=6), incision infection (n=3), incision dehiscence (n=2), fat liquefaction (n=4), grade b wound healing condition (n=14), grade c wound healing condition (n=7), and postoperative scar hyperplasia (n=13.48%).In conclusion, the use of subcutaneous cosmetic suture is of great significance to reduce scar hyperplasia, to reduce postoperative incision complications, and to improve the aesthetics of incision healing after caesarean section.

• 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: 18533414
• MDR Text Key: 333089789
• Report Number: 2210968-2024-00484
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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: 01/08/2024
• 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): Other
• Patient Sex: Female