MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 18IN 3-0 SA PS-1 PMP; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B102
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); Unspecified Infection (1930)
Date of Event	11/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a c-section on (b)(6) 2025 and barbed suture was used.Patient skin showed signs of infection & allergy to the suture after 10 days of follow-up.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 number, and no related 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: as per the hcp there were 2 patients on whom 1 foil each of stratafix monocryl was used.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?--> examination of allergic reaction & pus formation, patient status/ outcome / consequences --> yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> skin infection, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> 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: what is the surgeon¿s experience with this stratafix suture? please provide 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)? 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? was the fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? please describe the patient manifestations of the reported infection & allergy (location, severity, appearance, systemic or local infection).Please provide the onset date/time of infection & allergy from the initial surgical procedure.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 and sensitivities 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.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?.
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 health effect codes.Additional information was requested, and the following was obtained: - hcp was using stratafix for past 4 months for fascia closure & subcuticular closure in lscs.-surgeon did not observe any suture deficiency or anomaly before, during, after the suture placement.- gaping was seen after 2 weeks of patient discharge.-suture was properly placed at the initiation point using fixation loop and index part & reverse stitch was taken.-infection was local and managed by antibiotics.-onset of infection was after 2 weeks of discharge where wound gaping was seen.-patient did not have any known allergic conditions before operating.-culture test was performed and was positive -currently patient has been recovered from infection.

• Brand Name: SFXSPI MCL+ UNI UD 18IN 3-0 SA PS-1 PMP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23846653
• Report Number: 2210968-2025-14300
• Device Sequence Number: 9571892
• Product Code: GAM
• UDI-Device Identifier: 10705031236615
• UDI-Public: (01)10705031236615(17)260930(10)103Z5M
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K182873
• 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,Followup
• Report Date (Section B): 01/27/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: SXMP1B102
• Device Lot Number: 103Z5M
• 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: 11/29/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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: Unknown