BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60MM REINFORCEMENT

    MDR report key: 14020680 · Received April 6, 2022

    Report

    Report Number
    3005075853-2022-02079
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    March 10, 2022
    Report Date
    April 6, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    OXC
    UDI-DI
    10705036023296
    PMA / PMN Number
    K190937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNK. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PLEASE CLARIFY IF THERE WERE ANY ADVERSE PATIENT CONSEQUENCES DUE TO THIS EVENT? IF YES, PLEASE EXPLAIN IN DETAIL. NOT USED ON PATIENT. RECEIVED OUTSIDE OF TEMPERATURE RANGE THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON RECEIVED, THREE BOXES OF SIX HAD A RED DOT ON THE OUTSIDE AND INSIDE OF THE BOXES. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440435 ECHELON 60MM REINFORCEMENT OXC OXC ETHICON ENDO-SURGERY, LLC. ECH60R 10705036023296

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown