MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 60IN 0 S/A CTX LP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP990G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930)
Date of Event	12/01/2023
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.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.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)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? 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 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? what symptoms did the patient experience following the index surgical procedure? onset date? 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?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in (b)(6) 2023 and suture was used to sew muscle fascia tissue.About 7 days after the surgery, the wound was found with infection.Then the suture was removed.The patient is currently stable.Additional information was requested.
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: received information as following from sales rep via phone today.After investigation, the specific gender and age of the patient were unknown, and the patient underwent laparoscopic colorectal surgery in the hospital in 2023 (the specific date of surgery was unknown) (the specific patient's diagnosis was unknown).The surgeon used pdp990g to perform the muscle fascia sewing in the way of interrupted suturing during surgery, and the sewing operation was smoothly during surgery.About one week after the surgery, the patient had discharge of pus from the wound.The doctor found wound infection after examination.The wound drainage was performed.The patient was in stable condition currently.No subsequent adverse event report was received.Contacted with the sales rep today via phone, please refer to above information and other information requested is unknown.
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.Investigation summary : the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned sample determined that it was received one unopened sample that pertained to the product code pdp990g.In order to evaluate the condition of the returned sample, the packet was examined for visual defects: appearance, color package, wrinkles in the seal area, continuous seals, seal margins, over-sealing, damage (torn, punctured) and none was observed.The packet was opened, and the swage and attachment area were noted to be as expected.During the visual inspection, the suture was correctly placed on the winding former.The suture was dispensed without problems and examined along the strand and no anomalies or damage on the suture surface could be observed.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PDS+ VIO 60IN 0 S/A CTX LP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• 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: 18392111
• Report Number: 2210968-2023-10119
• Device Sequence Number: 14121545
• Product Code: NEW
• UDI-Device Identifier: 10705031048713
• UDI-Public: 10705031048713
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 01/26/2024

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: 06/30/2025
• Device Catalogue Number: PDP990G
• Device Lot Number: THMHCK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 01/02/2024; 01/12/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 01/11/2024; 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2023
• 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: Other
• Patient Sex: Unknown