MAUDE Adverse Event Report: ETHICON INC. VCL MESH KNIT UD 6INX6IN; MESH, SURGICAL, POLYMERIC

Model Number	VKMM
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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 and the following was obtained: please provide photos of the compromised packaging: don´t have.Which part of the packaging was damaged: shipping box, internal packaging, etc.? internal packaging.Do you believe this is a result of damage during shipping, or a manufacturing error? i couldn´t tell.Is the sterility of the device compromised? yes.When was it noticed that the packaging had a hole? in the operating room when the surgeon ask for the mesh, right before opening.Status of product return: discarded.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Component code: g07002 ¿ device not returned.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2023 and mesh was used.The internal package of the mesh was broken.This occurred in the operating room when the surgeon asked for the mesh, right before opening.There were no adverse patient consequences.Additional information was requested.

• Brand Name: VCL MESH KNIT UD 6INX6IN
• Common Device Name: MESH, SURGICAL, POLYMERIC
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16529421
• Report Number: 2210968-2023-01652
• Device Sequence Number: 14805342
• Product Code: FTL
• UDI-Device Identifier: 10705031056923
• UDI-Public: 10705031056923
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K810428
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Model Number: VKMM
• Device Catalogue Number: VKMM
• Device Lot Number: SD2ARB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2023
• Initial Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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: Female