MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 3INX6IN; MESH, SURGICAL, POLYMERIC

Model Number PMII

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 # (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.(b)(4).Additional information was requested and the following was obtained: how was the product purchased? the product was purchased in a proactive
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>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.Evaluation: product code: pm ii; lot no: v3010.Suture material: prolene mesh.Returned sample - 02 photographs of pm ii mesh lot v3010 overwrap pack provided for investigation.Visual comparison of complaint sample photo with approved artwork - received complaint sample photograph was visually inspected and compared with approved artwork of product code pmii and lot v3010, 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.On approved artwork all the batch traceability details (lot number, mrp, mfg, exp, etc) were mentioned in bold whereas on received complaint sample photograph all traceability details were mentioned in normal type, only price and expiry date in bold letters.Batch pmii v3010 was manufactured in year 2013 having manufacturing date 08/2013 and expiry date 07/2018 whereas on complaint sample photograph manufacturing date mentioned is 08/2021 and expiry date 07/2026.Which clearly differentiate the actual product as well as complaint sample.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.If further details are received at a later date a supplemental medwatch will be sent.

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: PROLENE MESH 3INX6IN
• 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: 14332415
• MDR Text Key: 299844728
• Report Number: 2210968-2022-03485
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031049024
• UDI-Public: 10705031049024
• Combination Product (y/n): N
• Reporter Country Code: BG
• PMA/PMN Number: K180829
• 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 Model Number: PMII
• Device Catalogue Number: PMII
• Device Lot Number: V3010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1