BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAVOY DILATOR

    MDR report key: 17305 · Received July 21, 1994

    Report

    Report Number
    17305
    Event Type
    Injury
    Date Received
    July 21, 1994
    Date of Event
    May 26, 1994
    Report Date
    June 3, 1994
    Manufacturer
    WILSON COOK
    Product Code
    KCF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT ESOPHAGEAL DILATION. A PERFORATION OF ESOPHAGUS OCCURRED NECESSITATING EXPLORATORY THORACTOMY AND REPAIR OF ESOPHAGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVOY DILATOR DILATOR/GUIDEWIRE KCF WILSON COOK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 * Required Intervention