BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON 2-0 45MM 70CM

    MDR report key: 13905353 · Received March 25, 2022

    Report

    Report Number
    2210968-2022-02191
    Event Type
    Malfunction
    Date Received
    March 25, 2022
    Date of Event
    January 12, 2022
    Report Date
    May 23, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: HOW WAS THE PRODUCT PURCHASED? THE PRODUCT WAS PURCHASED DURING THE PROACTIVE GBP MARKET SURVEY USING BI APP. IS THERE AN INDICATION OF HOW THE PRODUCT WAS DISTRIBUTED? WE HAVE HANDED OVER THE LEAD TO GLOBAL SECURITY FOR INVESTIGATION ON THE IDENTIFIED STORES TO UNDERSTAND THE SUPPLY CHAIN AND DISTRIBUTION. WILL KEEP YOU UPDATED ONCE WE RECEIVE INFORMATION. IS THERE ANY INDICATION OF THE SOURCE? NO. BASED ON THE PACKAGING, IS THERE ANY INDICATION OF WHICH MARKET THE ORIGINAL GENUINE PRODUCT MAY HAVE COME FROM? THE ORIGINAL GENUINE PRODUCTS IS MANUFACTURED IN INDIA WAS THE DEVICE USED ON A PATIENT? IF SO, WAS THERE ANY PATIENT CONSEQUENCE? THE SAMPLE PRODUCTS ARE IN THE CUSTODY OF THE GBP VENDOR IT IS NOT BEEN USED ON THE PATIENT. IS THE DEVICE AVAILABLE TO BE RETURNED FOR EVALUATION? IF SO, PLEASE PROVIDE THE STATUS OF THE RETURN SAMPLE AND ANY AVAILABLE TRACKING INFORMATION. YES. HOW MANY DEVICES ARE SUSPECTED TO BE COUNTERFEIT? 1 SAMPLE . INVESTIGATION SUMMARY- PRODUCT CODE: NW3336 AND LOT NO: V8083. SUTURE MATERIAL: ETHILON (MONOFILAMENT POLYAMIDE BLACK). INVESTIGATION: RECEIVED SAMPLE WAS SUBJECTED TO INVESTIGATION IN ORDER TO IDENTIFY THE NOVELTY OF THE PRODUCT. FOLLOWING IS THE DETAIL OF THE EVALUATION PERFORMED DURING INVESTIGATION. VISUAL COMPARISON OF COMPLAINT SAMPLE WITH RETAIN SAMPLE: RECEIVED COMPLAINT SAMPLE PHOTOGRAPH WAS VISUALLY INSPECTED AND COMPARED WITH RETAIN SAMPLE OF PRODUCT CODE NW3336 AND LOT V8083. UPON VISUAL INSPECTION IT HAS BEEN OBSERVED THAT THE PRODUCT PACKING WAS NOT MATCHING WITH RETAINED SAMPLE. COMPLAINT SAMPLE SINGLE BARRIER FOLDER WAS COMPARED WITH RETAINED SAMPLE SINGLE BARRIER FOLDER AND DISCREPANCY WAS OBSERVED IN COMPLAINT SAMPLE WITH RESPECT TO ETHICON APPROVED ARTWORK, COLOR CODING, INK TYPE, PRODUCT ARTWORK WRITING STYLE FONT AND FOLDER CUTTING. IN ADDITION, 2D BARCODE SCANNING WAS PERFORMED OVER SINGLE BARRIER FOLDER AND NON-COMPLIANT RESULTS WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4) DATE SENT TO THE FDA: 5/23/2022 ADDITIONAL INFORMATION: H6 H6 COMPONENT CODE: G07002 NO DEVICE RETURN H6 COMPONENT CODE: C22 - PHOTO ANALYSIS H3 INVESTIGATIONAL SUMMARY: INVESTIGATION: RECEIVED SAMPLE WAS SUBJECTED TO INVESTIGATION IN ORDER TO IDENTIFY THE NOVELTY OF THE PRODUCT. FOLLOWING IS THE DETAIL OF THE EVALUATION PERFORMED DURING INVESTIGATION. VISUAL COMPARISON OF COMPLAINT SAMPLE WITH RETAIN SAMPLE: RECEIVED COMPLAINT SAMPLE PHOTOGRAPH WAS VISUALLY INSPECTED AND COMPARED WITH RETAIN SAMPLE OF PRODUCT CODE NW3336 AND LOT B8083. UPON VISUAL INSPECTION IT HAS BEEN OBSERVED THAT THE PRODUCT PACKING WAS NOT MATCHING WITH RETAINED SAMPLE. COMPLAINT SAMPLE SINGLE BARRIER FOLDER WAS COMPARED WITH RETAINED SAMPLE SINGLE BARRIER FOLDER AND DISCREPANCY WAS OBSERVED IN COMPLAINT SAMPLE WITH RESPECT TO ETHICON APPROVED ARTWORK, COLOR CODING, INK TYPE, PRODUCT ARTWORK WRITING STYLE FONT AND FOLDER CUTTING. IN ADDITION, 2D BARCODE SCANNING WAS PERFORMED OVER SINGLE BARRIER FOLDER AND NON-COMPLIANT RESULTS WERE OBSERVED. CONCLUSION: COMPLAINT SAMPLE AND RETAIN SAMPLE COMPARISON INCLUDING VISUAL INSPECTION REVEALED THAT COMPLAINT SAMPLE IS NOT A GENUINE PRODUCT MANUFACTURED AT ETHICON AURANGABAD INDIA SITE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GLOBAL BRAND PROTECTION HAD CONDUCTED A COVERT MARKET SURVEY FOR SUTURES IN CITY OF (B)(6) IN THE MONTH OF (B)(6) 2022. DURING THE MARKET SURVEY, IT WAS IDENTIFIED THAT (B)(6) IS INVOLVED IN THE SALE OF COUNTERFEIT SUTURE PRODUCTS. A SAMPLE WAS PROCURED FROM (B)(6). ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851167 ETHILON 2-0 45MM 70CM SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. B8083

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown