MAUDE Adverse Event Report: ETHICON INC. PROLENE* POLYPROPYLENE MESH; MESH, SURGICAL, POLYMERIC

Model Number	PML
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a hernia repair procedure on (b)(6) 2023 and mesh was used.It was identified that the device does not have the secondary packaging (cardboard box) and that the import label and hologram are missing.Therefore, it is likely that the device was not imported from a source recognized by j&j.The device was used during the procedure which was successfully completed.There were no adverse patient consequences reported.Additional information has been requested.
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.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.How was the product purchased? is there an indication of how the product was distributed? is there any indication of the source? was the device used on a patient? if so, was there any patient consequence? 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.H6 component code: g07002 ¿ device not returned.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.
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: how was the product purchased? unknown is there an indication of how the product was distributed? unknown is there any indication of the source? unknown was the device used on a patient? if so, was there any patient consequence? the device was used on a patient, there´s no further information.
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.Photo analysis summary: during the visual analysis the following was observed: the photos show a prolene* polypropylene mesh package of the closed pml product code a label with additional barcode is visible on the package.In addition, the qr barcode was readable with the scanner with a result of(b)(4), the last six digits match the batch number.The lot number was entered into the database and the results were found to be in accordance with the process specifications and the lot number was manufactured by ethicon, diversion was confirmed.Ethicon products were not distributed by authorized affiliates.As part of our quality process, the manufacturing records for this batch serial number were reviewed and manufacturing standards were met prior to the release of this batch.As part of ethicon's quality process, all devices are manufactured, inspected and released to approved specifications.Additional monitoring of complaint information for potential safety signals will be conducted through complaint trends as part of post-market surveillance.

• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16860395
• Report Number: 2210968-2023-03224
• Device Sequence Number: 5957938
• Product Code: FTL
• UDI-Device Identifier: 10705031049031
• UDI-Public: 10705031049031
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K180829
• 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,Followup,Followup

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 Expiration Date: 07/31/2024
• Device Model Number: PML
• Device Catalogue Number: PML
• Device Lot Number: PJP454
• 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: 04/15/2023
• Supplement Date Received by Manufacturer: 04/28/2023; 06/27/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 05/09/2023; 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2019
• 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: Male