MAUDE Adverse Event Report: ETHICON INC. MALLA PROLENE 15CM X 15CM; MESH, SURGICAL, POLYMERIC

Catalog Number PMM1

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # pc- (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, 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.Component code: (b)(4) a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested and the following was obtained: how was the product purchased? the product was purchased in a proactive gbp market survey using bi app.Is there an indication of how the product was distributed? no information yet.Is there any indication of the source? we have passed the lead to gs for further investigation.Based on the packaging, is there any indication of which market the original genuine product may have come from? aurangabad & baddi was the device used on a patient? if so, was there any patient consequence? not used on patients.Please confirm how many devices are suspected to be counterfeit? confirm counterfeit as per plant quality through products images.Please confirm how many devices are being returned? unknown.Please provide the return status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.The products are still with gbp vendor in bangladesh.Product code - pmm1.Lot no - v6003.Suture material - prolene mesh.Returned sample - 02 photographs of pmm1 mesh lot v6003 inner folder pack provided for investigation.Visual comparison of complaint sample photo with retain sample approved artwork: received complaint sample photograph was visually inspected and compared with approved artwork of product code pmm1 and lot v6003, upon visual inspection multiple labeling and artwork related discrepancies were identified.Discrepancy in complaint sample photograph was observed with respect to approved artwork, color coding, label printing.Batch pmm1 v6003 was manufactured in year 2016 having manufacturing date 05/2016 and expiry date 04/2021 whereas on complaint sample manufacturing date mentioned is 09/2018 and expiry date 02/2023.Which clearly differentiate the actual product as well as complaint sample.Product - actual product was not received for investigation hence, functional product evaluation not performed.Conclusion - complaint sample photograph and approved artwork comparison including visual inspection revealed that provided photograph contains a complaint sample that is not a genuine product manufactured at ethicon site.

Event Description

Upon evaluation of returned photographs of a mesh device, it was found that the device did not compare with the approved artwork for the product code and lot number.Upon visual inspection, multiple labeling and artwork related discrepancies were identified.Discrepancy in complaint sample photograph was observed with respect to approved artwork, color coding, and label printing.There were no adverse patient consequences reported.

• Brand Name: MALLA PROLENE 15CM X 15CM
• Type of Device: 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 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14332398
• MDR Text Key: 299842803
• Report Number: 2210968-2022-03486
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: BG
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: PMM1
• Device Lot Number: V6003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1