MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS POLYGLACTIN 910 SUTURE; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	VCP442H
Medical Device Problem Code	Failure to Degrade (4084)
Health Effect - Clinical Codes	Pocket Erosion (2013); Impaired Healing (2378)
Date of Event	04/28/2026
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.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 clarify the number of sutures involved in each event of suture non absorption and emerging.Also please clarify the lot numbers associated with each patient for these complaints.Was the suture expected to be absorbed at 10-12 days? absorption for vicryl plus suture is essentially complete by 56-70 days.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.On what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? for the original intended closure, how were all layers closed? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? 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? will product be returned? if so, please provide the return date and tracking information.
Event or Problem Description
It was reported that a patient gave birth to a baby girl via vagina with loa position by cutting low forceps at the perineum side due to stagnation of presentation, fgr, once pregnancy, zero delivery, 39 weeks pregnancy and anemia during pregnancy on (b)(6) 2026 and suture was used intradermally.Ten days after operation, it was found that the suture had not been absorbed and was emerging, indicating incomplete/poor wound healing and requiring re suturing.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: d9, h3, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested but unavailable: please clarify the number of sutures involved in each event of suture non absorption and emerging.Also please clarify the lot numbers associated with each patient for these complaints.Was the suture expected to be absorbed at 10-12 days? absorption for vicryl plus suture is essentially complete by 56-70 days.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.On what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? for the original intended closure, how were all layers closed? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? 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? additional h6 component code: g07002 no device problem.Additional h3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that nine unopened samples were received for analysis.Product code vcp442h, lot 106jl7.In order to evaluate the condition of the returned samples, the packets were 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 packets were open, and the swage and attachment area were noted to be as expected in all needles.During the visual inspection, the sutures were correctly placed on the winding former.Sutures were dispensed without problems and examined along the strand and no anomalies could be observed.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.The event described could not be confirmed as the device performed without any difficulties noted.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: VICRYL PLUS POLYGLACTIN 910 SUTURE
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25280833
• Report Number: 2210968-2026-05749
• Device Sequence Number: 13205737
• Product Code: GAM
• UDI-Device Identifier: 10705031053298
• UDI-Public: (01)10705031053298(17)300131(10)106JL7
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K181652
• 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
• Report Date (Section B): 06/08/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VCP442H
• Device Lot Number: 106JL7
• 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: 05/08/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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