MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 2-0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP339H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
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.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral strength ¿ = 2360 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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure 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)? what was the tissue condition (normal, thin, calcified, fragile, diseased)? please describe any medical/surgical intervention required for this suture event including dates and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? 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? were any pre-op cleansing procedures changed recently? if yes, please describe 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? lot numbers? related medwatch reports: 2210968-2023-05507, 2210968-2023-05508.
Event or Problem Description
It was reported that a patient underwent an unknown cardiovascular surgery on an unknown date and suture was used on the subcutaneous.In the ward / icu, an infection occurred.The cause of the infection was unknown.A subcutaneous drain was placed because the patient was large and had thick subcutaneous skin.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.Additional information was requested, and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure, the patient was big.Date and name of index surgical procedure? cardiovascular surgery but detail is unk.The diagnosis and indication for the index surgical procedure? unkwhat was the initial approach for the index surgical procedure? (open, laparoscopic or other)? open.What was the tissue condition (normal, thin, calcified, fragile, diseased)? the patient was large and had thick subcutaneous skin.Please describe any medical/surgical intervention required for this suture event including dates and results.Unk.Did the operating surgeon observe.Any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? unk.Please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Unk.Please provide the onset date/time of infection from the initial surgical procedure.Unk were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? unk.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? unk were cultures performed? if so, please provide the results.Unk.How much and what type of drainage is present in this wound? unk.Were any pre-op cleansing procedures changed recently? if yes, please describe, unk other relevant patient history/concomitant medications? unk.What is the physician¿s opinion as to the etiology of or contributing factors to this event? the cause of the infection is unknown.What is the patient's current status? no problem.Lot numbers? unk.The surgeon was unwilling to tell us the detail because the cause of infection was not obvious.I certify that all information that are known/available has been disclosed.

• Brand Name: PDS+ VIO 27IN 2-0 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17431427
• Report Number: 2210968-2023-05509
• Device Sequence Number: 17835224
• Product Code: NEW
• UDI-Device Identifier: 10705031048096
• UDI-Public: 10705031048096
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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 Catalogue Number: PDP339H
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 09/08/2023
• 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 Sex: Unknown