MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 36IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J345H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Inflammation (1932); Itching Sensation (1943); Pain (1994); Pocket Erosion (2013); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an unknown procedure for a perineal laceration on (b)(6) 2023 and suture was used.On the 6th day after perineal laceration surgery, the patient complained of perineal pain and dehiscence.The patient had inflammation.The patient's vulvar wound was red, swollen, tingling, with exposed suture, and did not heal.The doctor cut off the surface suture and cleaned it with potassium permanganate solution.Additional information was requested.
Additional Manufacturer Narrative
(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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformities were identified.H6 component code: g07002 device not returned.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 name of index surgical procedure? the diagnosis and indication for the index surgical procedure? on what tissue was the suture used? what tissue dehisced? 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)? onset date/time of dehiscence? (# post op days).How was the dehiscence managed? was any re-suturing required? please describe any surgical intervention required for the wound dehiscence including date and findings.What post-op instructions were provided to the patient? were the post-op instructions followed by the patient? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? were any pre-op cleansing procedures changed recently? if yes, please describe 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
(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.Additional information was requested, and the following was obtained: received information as following from sales rep via phone today.After investigation, a 26-year-old female patient underwent perineal laceration repair in hospital on (b)(6) 2023.The surgeon used the j345h for perineal and subcutaneous tissue sewing in the way of interrupted suturing, and performed skin tissue sewing in the way of intradermal continuous suturing.The intraoperative sewing operation was smooth.6 days after the surgery, the patient returned to the hospital for reexamination due to perineal pain and incision dehiscence.The doctor found that the perineal incision was red and swollen, the suture at the incision site was discharged from the suture site, and the perineal incision dehiscence.The doctor removed the perineal skin suture and told the patient to use potassium permanganate to clean the wound.Then the wound healing condition of the patient was improved.No subsequent adverse events were reported.

• Brand Name: VCL CT BRD VIO 36IN 2-0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17405818
• Report Number: 2210968-2023-05438
• Device Sequence Number: 12243083
• Product Code: GAM
• UDI-Device Identifier: 10705031039094
• UDI-Public: 10705031039094
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022269
• 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): 09/13/2023

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: 11/30/2025
• Device Catalogue Number: J345H
• Device Lot Number: QP2AHU
• 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: 07/17/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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: Other
• Patient Age: 26 YR
• Patient Sex: Female