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	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Inflammation (1932); Pocket Erosion (2013); Local Reaction (2035); Insufficient Information (4580)
Date of Event	06/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).Component code: g07002.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.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.The following information was requested, but unavailable: was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed; other medication prescribed)? if so, please clarify.Was the suture removed in a routine post op procedure? was the suture removed in a reoperation procedure? was reoperation necessary to remove the suture and re close the wound? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a wound closure procedure on (b)(6) 2022 and suture was used.Post-op, the doctor used suture to sew the patient's wound due to perineal laceration, and the perineal suture was successfully hospitalized without discomfort.In the puerperium, there was suture reaction, the suture was not absorbed, and the wound was tingling, so the doctor removed the suture and the pain was relieved.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/14/2023.H6 component code: g07002 no device returned.The following additional information was received: after investigation, the event date should update to be 2022-jun-12.The suturing method used during surgery is interrupted suturing.The wound healing was improved after removing the suture knot.The wound healed completely at present, without infection.No subsequent adverse events were reported.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.

• 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 4403
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16230901
• Report Number: 2210968-2023-00426
• Device Sequence Number: 6871303
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: J345H
• Device Catalogue Number: J345H
• Device Lot Number: QP2AHZ
• 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: 12/27/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 02/14/2023
• 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
• Patient Age: 31 YR
• Patient Sex: Female