BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON FLEX 45 COMPACT

    MDR report key: 20250783 · Received September 18, 2024

    Report

    Report Number
    3005075853-2024-07016
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Report Date
    September 18, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036002697
    PMA / PMN Number
    K051002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/18/2024 D4: BATCH # UNK INVESTIGATION SUMMARY THE REPORTED EVENT FOR THE SC45A DEVICE WAS SUSPECT TAMPERING. THIS IS AN ANALYSIS OF THE PHOTOS SUBMITTED TO ETHICON ENDO SURGERY FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTO SHOWS A PACKAGING, CODE SC45A. IN ADDITION, THE TYVEK HAS A LABEL ATTACHED TO IT IN THE LOT AREA AND EXPIRATION DATE WITH LOT # K4CK6Z, EXP. DATE: 2026-08. LOT NUMBER WAS REVIEWED, AND IT BELONGS TO A SC45A DEVICE. THE EXPIRATION DATE PRINTED ON THE LABEL DOES NOT MATCH WITH THE EXPIRATION DATE RECORDED ON THE QUALITY TRACKING SYSTEM 2016-03-30. ADDITIONALLY, THE LABELS ON THE PACKAGING ARE NOT FROM J&J. BASED ON THE PHOTOS REVIEWED, THE TAMPERED PRODUCT IS CONFIRMED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ¿ HOW WAS THE PRODUCT PURCHASED? TEST PURCHASE PERFORMED BY A GBP SUPPLIER. ¿ IS THERE AN INDICATION OF HOW THE PRODUCT WAS DISTRIBUTED? NO, IT IS PART OF THE INVESTIGATION. ¿ 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? NO ¿ WAS THE DEVICE USED ON A PATIENT? IF SO, WAS THERE ANY PATIENT CONSEQUENCE? NO ¿ IS A PHOTO AVAILABLE OF THE PRODUCT? YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GBP LATAM TEAM PERFORMED A TEST PURCHASE IN COLOMBIA DUE TO A SUSPICIOUS SELLER. PRODUCT SC45A ¿ BATCH K4CK6Z - SUSPICIOUS OF TAMPERING ¿ THIS BATCH INVALID ¿ THERE IS INSCRIPTION ¿MUESTRA SIN VALOR COMMERCIAL¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2528879 ECHELON FLEX 45 COMPACT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. K4CK6Z 10705036002697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown