BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60MM REINFORCEMENT

    MDR report key: 12888388 · Received November 29, 2021

    Report

    Report Number
    3005075853-2021-07221
    Event Type
    Injury
    Date Received
    November 29, 2021
    Date of Event
    January 1, 2021
    Report Date
    November 22, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    OXC
    UDI-DI
    10705036023296
    PMA / PMN Number
    K190937
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).BATCH # UNK.DATE OF EVENT: ONLY EVENT YEAR KNOWN: 2021.AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING DOCUMENTATION COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED.AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS.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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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 POST OP TO AN UNKNOWN PROCEDURE THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AND ENDOSCOPY REVEALED THERE WAS 'STERILE FLUID BUILD UP ALONG THE STAPLE LINE.' NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1778151 ECHELON 60MM REINFORCEMENT OXC OXC ETHICON ENDO-SURGERY, LLC. ECH60R 10705036023296

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention