inforMED
MalfunctionGAM

Coated VICRYL

Received Jul 28, 2026 · Event occurred Jun 24, 2026

Report 2210968-2026-07496 · MDR key 50052988

Device

Generic name

Suture, Absorbable, Synthetic

Manufacturer

Ethicon Inc.

Catalog number

VCP303H

Lot number

109JMT

Product problems

  • Break

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The suture broke two times. No adverse patient consequences were reported. Additional information was requested.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (b)(4).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 requested, but unavailable: Received information as following from sales rep via phone today. Please refer to the event description, other information requested is unknown. Do you have any photos available for visual analysis? What is the current status of the patients?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.