BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON 2-0 45MM 70CM

    MDR report key: 13929535 · Received March 28, 2022

    Report

    Report Number
    2210968-2022-02185
    Event Type
    Malfunction
    Date Received
    March 28, 2022
    Date of Event
    January 27, 2022
    Report Date
    March 25, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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 (B)(4). 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 (B)(4) 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. INVESTIGATION SUMMARY: SAMPLE DETAILS: TWO PHOTOGRAPHS WERE PROVIDED OF PRODUCT CODE: NW3336 AND LOT NO: B9047. 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 B9047. 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. EVENT RELATED TO MW # 2210968-2022-02184 AND MW # 2210968-2022-02187.

    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) OCCURRED IN THE MONTH OF JANUARY 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
    336997 ETHILON 2-0 45MM 70CM SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. B9047

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown