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

Catalog Number	PDP317H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Inflammation (1932); Impaired Healing (2378); Fluid Discharge (2686)
Date of Event	07/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an abdominoplasty procedure on an unknown date and suture was used on the abdominal flap dermal plane.In about 3 weeks to 2 months, the patient developed a small increase in volume in the scar area, pain and subsequent leakage of viscous fluid and wound dehiscence in the lateral area without tension.The suture was exposed and the inflammation subsided as the suture material was removed.These phenomena were repeated many times in the same patient in different areas of the operative wound, having to remove the suture material repeatedly.The patient was managed with advanced healing until closure.
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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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 age, gender, weight, bmi at the time of index procedure.Date 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)? how was the suture tied (square knot or multiple knots one end)? were any pre-op cleansing procedures changed recently? if yes, please describe what tissue dehisced? is it known how the wound dehisced? did the sutures untie, break, or pull out of the tissue? were there any patient stress factors that led to the suture untying, breaking or pulling out of the tissue? onset date/time of dehiscence? (# post op days) how was the dehiscence managed? were there any pre-existing signs/symptoms of active inflammation/infection prior to this surgical procedure? were cultures performed? results? please describe any surgical intervention required for the wound dehiscence including date and findings.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? please describe the appearance of the suture during the second procedure.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? if applicable, will product be returned? if so, please provide the return date and tracking information.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: tamabl - expiration date: dec/31/2027 date of mfg.: jan/2/2023 slmljk - expiration date: sep/30/2024 date of mfg.: oct/18/2022 skmdll - expiration date: aug/31/2024 date of mfg.: sep/8/2022 tamasm - expiration date: dec/31/2027 date of mfg.: jan/03/2023 a manufacturing record evaluation was performed for the possible finished device lots, and no non-conformances were identified.
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 investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned devices.The returned product determined that it was received, three suture pieces that pertain to the product code pdp317h.During the visual inspection of the suture pieces, body fluids noted in each piece of the suture.Also, the ends appear to be cut probably by a surgical instrument, and in one suture piece was found a knot.This is consistent with the removal of the suture from the patient.The product code pdp317 contains an absorbable suture.As the sample was received open, and the time of exposure to the environment cannot be determined.Due to the condition of the returned sample, the functional test could not be performed.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached on the cause of the reported event.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: PDS+ VIO 27IN 2-0 S/A SH
• 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: 17860638
• Report Number: 2210968-2023-07323
• Device Sequence Number: 17624706
• Product Code: NEW
• UDI-Device Identifier: 10705031048034
• UDI-Public: 10705031048034
• Combination Product (Y/N): Y
• Initial Reporter Country: CI
• 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): 10/30/2023

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: PDP317H
• 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: 09/11/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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