MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 1 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP371H
Medical Device Problem Code	Failure to Degrade (4084)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Purulent Discharge (1812); Inflammation (1932); Pain (1994); Fluid Discharge (2686); Swelling/ Edema (4577)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent vaginal delivery on (b)(6) 2025 and suture was used on a perineum first degree laceration.The suturing was successful.The patient was discharged one day later.Three days after the surgery, the patient came to the hospital for treatment due to swelling and pain in the perineal wound.Upon examination, a 1 x 2cm rupture was found at the site of the perineal fissure, with purulent discharge, inflammation and unabsorbed suture.Incision suture was removed, medical wound care membrane was used to care for the wound, and cefaclor sustained-release tablets were used to resist infection.After 55 days of operation, the perineal wound healed well.Additional information was requested.
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.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.Additional information was requested, and the following was obtained: what is the procedure date (dd/mm/yyyy)? (b)(6) 2025.What date did the swelling and pain occur on (dd/mm/yyyy)? (b)(6) 2025.Was there any medical or surgical intervention performed (re-closure; prescription medication)? if so, please specify.If medication was required, please clarify if it was prescription strength.What is the most current patient status? please refer to the event description, other information requested is unknown.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: the patient's demographic information including age, gender, weight, bmi at the time of index procedure.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)? how was the suture tied (square knot or multiple knots one end)? did the patient experience a wound dehiscence? if yes, what tissue dehisced? did the sutures untie, break, or pull out of the tissue? were there any patient stress factors that led to the suture untying, breaking or pulling out of the tissue? onset date/time of dehiscence? (# post op days) how was the dehiscence managed? please describe any surgical intervention required for the wound dehiscence including date and findings.Did the patient have an infection? were cultures performed? if so, please provide the results.Were any pre-op cleansing procedures changed recently? if yes, please describe did the suture have slow absorption? was the suture expected to be absorbed upon examination? absorption for vicryl suture is essentially complete by 56-70 days.The absorption of vicryl rapide¿ is essentially complete by 42 days.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? 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.Are there any photos available? please describe the appearance of the suture during the second procedure.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?.
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.Additional information: h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested but unavailable: the patient's demographic information including age, gender, weight, bmi at the time of index procedure.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)? how was the suture tied (square knot or multiple knots one end)? did the patient experience a wound dehiscence? if yes, what tissue dehisced? did the sutures untie, break, or pull out of the tissue? were there any patient stress factors that led to the suture untying, breaking or pulling out of the tissue? onset date/time of dehiscence? (# post op days) how was the dehiscence managed? please describe any surgical intervention required for the wound dehiscence including date and findings.Did the patient have an infection? were cultures performed? if so, please provide the results.Were any pre-op cleansing procedures changed recently? if yes, please describe did the suture have slow absorption? was the suture expected to be absorbed upon examination? - absorption for vicryl suture is essentially complete by 56-70 days.- the absorption of vicryl rapide¿ is essentially complete by 42 days.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? 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.Are there any photos available? please describe the appearance of the suture during the second procedure.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?.

• Brand Name: VCL+ VIO 36IN 1 S/A CTX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23761223
• Report Number: 2210968-2025-13796
• Device Sequence Number: 10105345
• Product Code: GAM
• UDI-Device Identifier: 10705031052857
• UDI-Public: (01)10705031052857(17)290731(10)102QJX
• 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): 02/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VCP371H
• Device Lot Number: 102QJX
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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: Required Intervention
• Patient Sex: Female