MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 1 S/A CTB-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCPB341H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Local Reaction (2035)
Date of Event	09/13/2023
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 ¿ = 472 g/m.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.Procedure date and event date are both (b)(6) 2023.Please clarify as event occurred one week after the procedure.Please provide the patient's demographic information including weight, bmi at the time of index procedure date of 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)? how was the suture originally tied (multiple knots, square knot, etc.)? 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.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?.
Event or Problem Description
It was reported that a patient underwent a right total hip arthroplasty on (b)(6) 2023 and suture was used.After the surgery, the patient complained of incision pain without obvious abnormalities.One week later, the patient complained of pain at the right hip wound with obvious fixed tenderness, located at the knot during the right total hip arthroplasty surgery.The patient experienced post-op inflammation.There was no significant increase in blood count and no obvious abnormality was found on the dr film.Considering the suture rejection reaction, the patient's pain symptoms were significantly relieved after anti-inflammatory treatment with dexamethasone, and residual pain remained after discharge.Additional information was requested.
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested but unavailable: procedure date and event date are both (b)(6) 2023.Please clarify as event occurred one week after the procedure.Please provide the patient's demographic information including weight, bmi at the time of index procedure date of 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)? how was the suture originally tied (multiple knots, square knot, etc.)? 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.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? --contacted with the sales rep today via phone, please refer to the event description, other information requested is unknown.Corrected information: h6 type of investigation.
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.Additional information was requested, and the following was obtained: received information as following from sales rep via phone today.After investigation, on (b)(6) 2023, the patient underwent a right total hip arthroplasty in which the muscular fascia was sewed with sutures.On (b)(6) 2023, the patient complained of pain at the right hip wound, with obvious fixed tenderness, which was located at the knot of intraoperative sewing site (vcpb341h and vcp840d).After symptomatic treatment mentioned in event description, the patient's pain was improved.No subsequent adverse event report was received.Please update the event date to be (b)(6) 2023, and add another related product of vcp840d with unknow lot number.Note: related events reported via 2210968-2023-09505.

• Brand Name: VCL+ VIO 27IN 1 S/A CTB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17904521
• Report Number: 2210968-2023-07589
• Device Sequence Number: 7561363
• Product Code: GAM
• UDI-Device Identifier: 10705031056411
• UDI-Public: 10705031056411
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2023

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: 01/31/2026
• Device Catalogue Number: VCPB341H
• Device Lot Number: RBMDJA
• 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: 10/02/2023
• Supplement Date Received by Manufacturer: 10/12/2023; 11/15/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 10/30/2023; 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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: 60 YR
• Patient Sex: Male