MAUDE Adverse Event Report: ETHICON INC. SILK BLK 10X30IN 0 NON NDL; SUTURE, NONABSORBABLE, SILK

Catalog Number	SA86G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Erythema (1840); Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Swelling/ Edema (4577)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a cesarean section on an unknown date and suture was used to sew subcutaneously.Post-op, the patient experienced suture extrusion and infection.Around 1 week after the surgery, the wound was found with suture extrusion, redness and abscess.Debridement was done, the patient is currently stable.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Attempts have been made to retrieve the device.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.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, gender, weight, bmi at the time of index procedure date of index surgical procedure? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? 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.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? what is the patient's current status? surgeon¿s name?.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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: b3.Additional information: d9, h3, h6.Additional information was requested, and the following was obtained: the event date should update to be (b)(6) 2025.After investigation, the patient underwent a cesarean section surgery in 2025 (specific procedure date unknown).The surgeon used sa86g for interrupted suturing of subcutaneous tissue of the incision during the surgery.The information of the medical devices used at other tissue layers and the specific surgical process was unknown.About one week after the surgery ((b)(6) 2025), the doctor found thread emerging from the patient's wound, with wound redness, swelling, exudation and pain.The doctor then disinfected the wound and removed the suture.It was unknown whether laboratory examination or other treatment measures were taken during this period.The patient's wound condition was improved after symptomatic treatment, and no subsequent adverse event report was received.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 of index surgical procedure? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? 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.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? what is the patient's current status? surgeon¿s name? additional h3 investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that it was received one piece of knotted suture that pertain to product code sa86g, the rest of suture was not received.The suture was examined and it was knotted and the suture end was noticed damaged, no further functional test could be carried out due to the condition of the returned suture.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review: the manufacturing and raw material records could not be reviewed as the batch/lot number is unknown.

• Brand Name: SILK BLK 10X30IN 0 NON NDL
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23533591
• Report Number: 2210968-2025-12715
• Device Sequence Number: 9140953
• Product Code: GAP
• UDI-Device Identifier: 10705031050297
• UDI-Public: 10705031050297
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946173
• 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): 12/11/2025

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: SA86G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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