BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK ESOPHAGEAL DILATOR SET

    MDR report key: 203790 · Received December 29, 1998

    Report

    Report Number
    1820334-1998-00134
    Event Type
    Injury
    Date Received
    December 29, 1998
    Date of Event
    November 24, 1998
    Report Date
    November 30, 1998
    Manufacturer
    COOK INC.
    Product Code
    KCF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A NORMAL ESOPHAGUS. THE ESOPHAGEAL DILATOR WAS PLACED AND PLACEMENT WAS SATISFACTORY. THE FOLLOWING MORNING, THE PT HAD AN EXTREMELY SORE THROAT WHICH CONTINUED ALL DAY. PT WAS PLACED AN ANTIBIOTICS THAT NIGHT. TESTS WERE PERFORMED AND A PERFORATION IN THE NECK WAS NOTED AT THE C4-C5 LEVEL. THE PT WAS TAKEN TO SURGERY ON NOVEMEBR 26, 1998. A LEFT NECK EXPLORATION AND DRAINAGE WAS COMPLETED AT THAT TIME. PT IS DOING OK FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK ESOPHAGEAL DILATOR SET DILATOR SET KCF COOK INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention