MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 4-0 S/A SH-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP310H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Pain (1994); Local Reaction (2035); Impaired Healing (2378)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The following information was requested but unavailable: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? did the patient have an infection? please describe any medical/surgical intervention required for this suture event including dates and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? were any pre-op cleansing procedures or products changed recently? if yes, please describe.Does the patient have a known allergic history to any medical devices, food and/or medication? was allergy testing performed? if so, please describe with results.Were cultures performed? if so, please provide the results.How much and what type of drainage is present in this wound? are there any photos available? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.
Event or Problem Description
It was reported that a patient underwent a c-section on (b)(6) 2025 and suture was used.The patient underwent the surgery due to scar uterus.During the surgery, the doctor used suture for intradermal cosmetic suturing.Two months after delivery, the patient's wound developed a knot reaction, causing local pain, and foreign objects and pus were squeezed out after bulging.The patient had poor wound healing.The area was cleaned up and the dressing was changed.Additional information was requested.Clean up and change the dressing.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: b1, b2, h1 - additional information was received and it was reported that the device is not involved in this complaint.Therefore, this medwatch report is being voided.

• Brand Name: VCL+ VIO 27IN 4-0 S/A SH-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23416177
• Report Number: 2210968-2025-12277
• Device Sequence Number: 13398304
• Product Code: GAM
• UDI-Device Identifier: 10705031149755
• UDI-Public: (01)10705031149755(17)290630(10)102DHR
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: VCP310H
• Device Lot Number: 102DHR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown