BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALONEY DILATORS

    MDR report key: 17308 · Received July 21, 1994

    Report

    Report Number
    17308
    Event Type
    Injury
    Date Received
    July 21, 1994
    Date of Event
    June 17, 1994
    Report Date
    June 29, 1994
    Manufacturer
    MEDOVATIONS
    Product Code
    KCF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    FOLLOWING ESOPHAGEAL DILATION, PATIENT DEVELOPED SEVERE ABDOMINAL PAIN, DIAPHORESIS; SUSTAINED PERFORATION OF STOMACH. UNDERWENT EXPLORATORY LAPAROTOMY AND THORACOTOMY WITH REPAIR OF PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALONEY DILATORS ESOPHAGEAL DILATORS KCF MEDOVATIONS 40 FR = 1210 - 14

    Patients

    Seq Age Sex Outcome Treatment
    1 54 * Required Intervention