BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAHONEY DILATOR

    MDR report key: 64328 · Received December 27, 1996

    Report

    Report Number
    64328
    Event Type
    Injury
    Date Received
    December 27, 1996
    Date of Event
    July 17, 1996
    Report Date
    September 25, 1996
    Manufacturer
    PILLING INSTRUMENT CO.
    Product Code
    KNQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LAPAROSCOPIC NISSEN FUNDOPLICATION PERFORMED WITH 50 MM DILATOR. RETURN TO SURGERY TWO DAYS POST-OP. PERFORATION OF ESPOHAGUS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAHONEY DILATOR 50 FR MAHONEY DILATOR KNQ PILLING INSTRUMENT CO. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R