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

Catalog Number	VCP304H
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Failure to Degrade (4084)
Health Effect - Clinical Codes	Erythema (1840); Skin Discoloration (2074); Impaired Healing (2378); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a radical mastectomy for breast cancer on (b)(6) 2026 and suture was used to close the incision.On the 8th day after surgery, the patient showed poor wound healing, local skin redness and swelling, white skin edge color, and visible exudate under compression.After active dressing changes and conservative treatment until the 11th day after surgery, there was no significant improvement in the wound condition, and debridement and suturing surgery were performed.The doctor found during the surgery that the above-mentioned suture was not absorbed in the body and was removed.Based on comprehensive clinical process analysis, considered the correlation between poor wound healing and poor suture suction in the patient.Strengthen incision care and observation after surgery to ensure the healing process after secondary suturing.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.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.Additional information was requested, and the following was obtained: on what tissue was the suture used? -subcutaneous tissue.How was the suture placed (interrupted or continuous)? interrupted what is the patient's current status? the patient's current condition has improved.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.Were any concomitant procedures performed? what was the tissue condition (normal, thin, calcified, fragile, diseased)? for the original intended closure, how were all layers closed? how was the suture originally tied (multiple knots, square knot, etc.)? were there any pre-existing signs/symptoms of active inflammation/infection prior to this surgical procedure? were cultures and sensitivities performed? if so, please provide the results.Were there all symptoms resolved after suture removal and replacement procedure? were any pre-op cleansing procedures changed recently? if yes, please describe did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event?.
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.Corrected information: c1 name and strength.
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 was requested, and the following was obtained: after investigation, the suture involved was used for interrupted suturing of subcutaneous tissue.The patient's wound healing was improved after symptomatic treatment, and no subsequent adverse event report was received.

• Brand Name: VCL+ VIO 27IN 4-0 S/A RB-1
• 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: 24323402
• Report Number: 2210968-2026-01585
• Device Sequence Number: 9475945
• Product Code: GAM
• UDI-Device Identifier: 10705031149748
• UDI-Public: (01)10705031149748(17)300531(10)1098AZ
• 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,Followup
• Report Date (Section B): 03/30/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: VCP304H
• Device Lot Number: 1098AZ
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 02/03/2026; 03/18/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 02/12/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2025
• 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: Unknown