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

Model Number	J345H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
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-conformances 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 weight, bmi at the time of index procedure on what tissue was the suture used/location of suture placement? did the wound dehisce? 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)? what instruments were used in this procedure to handle the suture? please describe the appearance of the suture during the second procedure (re-suturing).Was the suture found broken? were there any precipitating stress factors for the sutures untying, breakage or pulling out of the tissue? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what post-op instructions were provided to the patient? were the post-op instructions followed by the patient? 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?.
Event or Problem Description
It was reported that a patient underwent a lateral episiotomy procedure on (b)(6) 2023 and suture was used.Post-op, on the 26th day after the procedure, the patient complained of perineal pain and rupture.The patient had inflammation.The patient's external genitalia wound was red, swollen, stinging, exuding, with exposed suture, and does not heal.The doctor cut off the surface suture of the external genitalia, sutured it again, and washed it with potassium permanganate.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.The following information was requested but unavailable: please provide the patient's demographic information including weight, bmi at the time of index procedure.On what tissue was the suture used/location of suture placement? did the wound dehisce? 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)? what instruments were used in this procedure to handle the suture? please describe the appearance of the suture during the second procedure (re-suturing).Was the suture found broken? were there any precipitating stress factors for the sutures untying, breakage or pulling out of the tissue? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what post-op instructions were provided to the patient? were the post-op instructions followed by the patient? 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? --contacted with the sales rep today via phone, please refer to the event description and other information requested is unknown.(b)(4).Corrected information: h6 type of investigation.
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.Additional information was requested, and the following was obtained: received information as following from sales rep via phone today.After investigation, a 32-year-old female patient underwent episiotomy repair in hospital on (b)(6) 2023.The surgeon used the j345h to perform the perineal, subcutaneous and skin tissue sewing in the way of continuous suturing.The intraoperative sewing was operated smoothly.26 days after the surgery, the patient returned to the hospital for reexamination due to perineal pain and incision dehiscence.The doctor found that the patient had perineal incision swelling and exudation, 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 performed the suturing again.The potassium permanganate was used to clean the wound.Then the patient's wound healing was improved.No subsequent adverse event reports were received.

• 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: 16825994
• Report Number: 2210968-2023-03063
• Device Sequence Number: 6987431
• 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,Followup
• Report Date (Section B): 06/07/2023

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 Model Number: J345H
• Device Catalogue Number: J345H
• Device Lot Number: SK2DKK
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 04/28/2023; 05/23/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 05/10/2023; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2022
• 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 Age: 32 YR
• Patient Sex: Female