MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 2-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP443H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent to the hcp: 2/9/2023.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 g/m.Component code: g07002 device not returned.Attempts are being 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 name of suture/suture type? product code/lot? date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? please describe the patient manifestations of the reported reaction (location, severity, appearance, systemic or local reaction).Please provide the onset date/time of the reaction from the initial procedure.Please describe the reason debridement was required for the reaction.Please describe the surgical intervention/debridement required, including dates and results.Please describe any medical intervention required to treat the patient condition including medication name and results.Were any pre-op cleansing procedures or products changed recently? if yes, please describe.Does the patient have a known allergic history to any medical devices, food and/or medication? was allergy testing performed? if so, please describe with results.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? are there any photos available? if applicable, will product be returned? if so, please provide a contact name and address where a shipper kit can be sent.Please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Please provide the onset date/time of infection from the initial surgical procedure.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.How much and what type of drainage is present in this wound? please describe any medical intervention performed including medication name and results.
Event or Problem Description
It was reported that a patient underwent an orthopedic procedure on an unknown date and suture was used.Post-op, the patient had a superficial wound problem with reactive changes around the suture.The patient went on to develop a formal infection.The patient had to be taken back to debride the wound.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 2/22/2023 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.Additional information was requested, and the following was obtained: (b)(6) 2022 left shoulder patient initials (b)(6) mr# returned (b)(6) for wound debridement mod leukocytes, no bacteria or fungal growth.
Additional Manufacturer Narrative
Product complaint # (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.Additional information was requested, and the following was obtained: dy 67yr male 97 kg left shoulder replacement osteoarthritis returned x1 for debridement.Additional information: d4 - the actual device batch number associated with this event is not known.Two possible batch numbers are reported as follows: sj2amd, rp2acd.
Additional Manufacturer Narrative
Product complaint # (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.Additional information was requested, and the following was obtained: we do not record lot numbers of suture used on patients.The best i can give you is the 2 lot numbers we had on our shelves during the time these incidences occurred.Both lots were pulled when the issues were discovered, new suture was ordered in and the surgeon actually changed to a completely different suture after he had this issue additional information: d4, h4 - the actual device batch number associated with this event is not known.Two possible batch numbers are reported as follows: sj2amd mfg.Date: 08/16/2022, expiry date: 07/31/2027; rp2acd mfg.Date: 12/05/2021, expiry date: 11/30/2026.A manufacturing record evaluation was performed for the possible finished device lots, and no non-conformances were identified.

• Brand Name: VCL+ UD 27IN 2-0 S/A FS-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: 16336070
• Report Number: 2210968-2023-00936
• Device Sequence Number: 20438060
• Product Code: GAM
• UDI-Device Identifier: 10705031053311
• UDI-Public: 10705031053311
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/28/2023

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: VCP443H
• Device Catalogue Number: VCP443H
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 02/16/2023; 02/23/2023; 03/13/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 02/22/2023; 02/28/2023; 03/16/2023
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 97 KG