MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A UR-6; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP603H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Purulent Discharge (1812); Hypersensitivity/Allergic reaction (1907); Insufficient Information (4580)
Date of Event	08/29/2025
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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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: did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? yes, did the patient require revision surgery or hardware removal? no, if no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? additional prescriptions, second intention wound closure, patient status/ outcome / consequences yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? allergic reaction, inflammation, wound dehiscence, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe medical prescriptions & wound management.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.Please provide the patient's demographic information including age, 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)? was the vicryl plus suture surgically removed? or was it trimmed in the office? 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? what was the onset date for the oozing and wound dehiscence? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? if so, please provide the results.How much and what type of drainage is present in this wound? were any pre-op cleansing procedures 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.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? lot number?.
Event or Problem Description
It was reported that a patient underwent a minimally invasive lumbar hernia surgery on (b)(6) 2025 and suture was used to close the surgical wound for fascial closure.On (b)(6) 2025, after being discharged, the patient told the doctor that the wound was oozing and dehiscing.The doctor immediately prescribed medication to prevent infection and began wound management.Reviewing the incident with the doctor, he stated that the patient's case was not related to a surgical site infection, as there was re-epithelialization at the wound edges and there weren´t any other ssi alarm data.Rather, it was an allergic reaction to the suture.Once the stitch of suture was removed, the inflammatory reaction subsided, and a secondary wound closure was possible.Additional information was requested.

• Brand Name: VCL+ VIO 27IN 0 S/A UR-6
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.; 1000 route 202; raritan 08869 0151
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23361370
• Report Number: 2210968-2025-12155
• Device Sequence Number: 8871678
• Product Code: GAM
• UDI-Device Identifier: 10705031054394
• UDI-Public: 10705031054394
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: VCP603H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male