BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE MESH 3INX6IN

    MDR report key: 14332395 · Received May 8, 2022

    Report

    Report Number
    2210968-2022-03487
    Event Type
    Malfunction
    Date Received
    May 8, 2022
    Date of Event
    February 19, 2022
    Report Date
    May 8, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    UDI-DI
    10705031049024
    PMA / PMN Number
    K180829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE NOT RETURNED. 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. 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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295729 PROLENE MESH 3INX6IN MESH, SURGICAL, POLYMERIC FTL ETHICON INC. PMII V3010 10705031049024

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown