BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER ADJUSTABLE BI-FLANGED FISTULA

    MDR report key: 4501970 · Received February 6, 2015

    Report

    Report Number
    2025182-2015-00001
    Event Type
    Injury
    Date Received
    February 6, 2015
    Date of Event
    January 28, 2015
    Report Date
    January 28, 2015
    Manufacturer
    HELIX MEDICAL, LLC
    Product Code
    EWL
    PMA / PMN Number
    K130736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE STEM OF THE FISTULA PROSTHESIS BROKE WHEN THEY WERE PLACING IT IN A PATIENT. THE PHYSICIAN REPORTED THAT THEY HAD TO TAKE THE PATIENT TO THE OPERATING ROOM TO RETRIEVE THE ESOPHAGEAL SIDE OF THE FISTULA PROSTHESIS. THE PHYSICIAN SUCCESSFULLY REMOVED THE ESOPHAGEAL SIDE OF THE DEVICE. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88715 BLOM-SINGER ADJUSTABLE BI-FLANGED FISTULA FISTULA PROSTHESIS EWL HELIX MEDICAL, LLC FM1004 1097806

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention