MAUDE Adverse Event Report: Ethicon Inc. Coated VICRYL Plus; Suture, Absorbable, Synthetic

Catalog Number	VCP504G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an entropion or ectropion repair and suture was used.The suture was dissolving before the patient's eye was healed.The patient had to be brought back for revision surgery on (b)(6) 2026 and a different type of suture was used.No further issues were noted.Patients healed appropriately.Device is available for return.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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.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: a photo with the following 3 products was sent: vicryl plus 4-0/ vcp504g lot # 10cp4a vicryl plus 5-0/ vcp493g lot # 10cq7q vicryl 4-0/ j494h lot # xlbbpqx0 which product is involved in the event for each patient? is vcp493g 10cq7q vicryl plus 5-0 related to this event? if yes, please specify the issue.Is j494h xlbbpqx0 vicryl 4-0 related to this event? if yes, please specify the issue.For each patient please provide the following information: please provide a timeline with details of when the issues occurred.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? were any concomitant procedures performed? 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.)? 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? did the patient have a wound dehiscence? did the suture break? if so, where was the break noted (termination, middle, end)? onset date/time of early dissolving/possible dehiscence? (# post op days) please describe the appearance of the suture during the second procedure.Were there any precipitating patient stress factors that led to the suture breakage? are patient photos available? 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.

• Brand Name: Coated VICRYL Plus
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50615798
• Report Number: 2210968-2026-08980
• Device Sequence Number: 10710070
• Product Code: GAM
• UDI-Device Identifier: 10705031053922
• UDI-Public: (01)10705031053922(17)301130(10)10CP4A
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K181652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/04/2026

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: VCP504G
• Device Lot Number: 10CP4A
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2025
• 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