MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 2-0 S/A CT-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP333H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 275 ug/m.(b)(4).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.Lot number: procedure date: event onset date: was medical or surgical intervention needed ? if so, what intervention was performed ? additional information: the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: scbcgcw0, rkbcmsw0.
Event or Problem Description
It was reported that a patient underwent an orthopedic procedure on (b)(6) 2022 and suture was used on the subcutaneous tissue.The patient developed an infection in the subcutaneous layer.The surgeon changed their technique with type of needle.The patient developed an infection.The ssi is not yet identified if it came from the suture, additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 additional information: d4, h4 ¿ the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: scbcgcw0, rkbcmsw0 device history lot: a manufacturing record evaluation was performed for the finished device vcp333h; (b)(6) number, and no non-conformances were identified.Manufacturing date: 03.11.2022 expiration date: 02.28.2025 a manufacturing record evaluation was performed for the finished device vcp333h; rkbcmsw0 number, and no non-conformances were identified.Manufacturing date: 09.20.2021expiration date: 08.31.2024 additional information was requested, and the following was obtained: were all sutures used in a single procedure ?there where reported multiple ssi after 6 weeks if not, how many patients were involved ? as i know so far 4 please indicate per patient: product code:not possible they can not identify lot number: as reported procedure date: several operations event onset date:- was medical or surgical intervention needed ? if so, what intervention was performed ?: ssi treatment.Related medwatch reports: 2210968-2022-05402, 2210968-2022-05403, 2210968-2022-05404, 2210968-2022-05405.

• Brand Name: VCL+ VIO 27IN 2-0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 14992463
• Report Number: 2210968-2022-05401
• Device Sequence Number: 1777364
• Product Code: GAM
• UDI-Device Identifier: 10705031052390
• UDI-Public: 10705031052390
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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: VCP333H
• Device Catalogue Number: VCP333H
• 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: 06/13/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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