BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORTHGATE RESEARCH SD-1

    MDR report key: 12643 · Received March 23, 1994

    Report

    Report Number
    12643
    Event Type
    Injury
    Date Received
    March 23, 1994
    Date of Event
    March 21, 1994
    Report Date
    March 23, 1994
    Manufacturer
    NORTHGATE RESEARCH DIV. MONAGHAN MEDICAL CORP.
    Product Code
    FFK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE END OF THE LITHOTRIPTOR ELECTRODE CABLE "LOST" IN PT, LODGED SUBMUCOSAL TO URETER IN AREA WHERE URETERAL STONE WAS IMPACTED. LEFT IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORTHGATE RESEARCH SD-1 STONE DISINTEGRATOR FFK NORTHGATE RESEARCH DIV. MONAGHAN MEDICAL CORP. ACMI EL-115, ACMI AEH-2 271191

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization