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

Catalog Number	VCP493H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/20/2026 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, the following was obtained: ¿ did the needle fall into the patient? if yes, was the needle piece removed from the patient during the same procedure? ¿ were there any patient consequences? ¿ please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) --received information as following from sales rep via phone today.Please refer to the event description, other information requested is unknown.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 following information was received: the correct lot number is " skmrkx" after confirmation with the sales via phone on 15/may/2026 lot number skmrkx 's quantity to be returned should be 14.And a new ip needs to be added: product code: vcp493h, lot number: 103uuu, quantity involved: 1, quantity to be returned:1.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6)2026 and suture was used.This case is from health authority.The patient had a skin laceration around the lower lip and underwent suturing.During the suturing process, the needle pull off issue happened.New suture was replaced for sewing.There were no patient consequences reported.Additional information was requested.

• Brand Name: VICRYL PLUS POLYGLACTIN 910 SUTURE
• 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 ; 3035526892
• MDR Report Key: 25229244
• Report Number: 2210968-2026-05583
• Device Sequence Number: 10183910
• Product Code: GAM
• UDI-Device Identifier: 10705031150034
• UDI-Public: (01)10705031150034(17)290930(10)103UUU
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VCP493H
• Device Lot Number: 103UUU
• 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: 05/14/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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
• Patient Sex: Unknown