BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60MM REINFORCEMENT

    MDR report key: 11753322 · Received April 30, 2021

    Report

    Report Number
    3005075853-2021-02419
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    January 1, 2021
    Report Date
    April 1, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    OXC
    UDI-DI
    10705036023296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT WAS THE PATIENT¿S DIAGNOSIS? WAS THE EVENT RELATED TO A STRICTURE, ANASTOMOTIC LEAK OR BOTH? WERE THERE ANY DIFFICULTIES WITH DEVICE IN INITIAL PROCEDURE? WERE THERE ANY STAPLE FORMATION ISSUES NOTED THROUGHOUT CARE OF PATIENT? HOW WAS THE STRICTURE OR LEAK ADDRESSED? WHAT IS THE CURRENT PATIENT STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OPERATIVE TO A BARIATRIC REVISION SLEEVE TO BYPASS PROCEDURE, THE PATIENT PRESENTED WITH FEVER. UPON ENDOSCOPY, A STRICTURE WAS DISCOVERED ALONG WITH FREE AIR IN THE ABDOMEN. THE PATIENT IS CURRENTLY ADMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652301 ECHELON 60MM REINFORCEMENT SURGICAL MESH OXC ETHICON ENDO-SURGERY, LLC. 10705036023296

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention