BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALECOT CATHETER

    MDR report key: 546967 · Received September 30, 2004

    Report

    Report Number
    1820334-2004-00600
    Event Type
    Injury
    Date Received
    September 30, 2004
    Date of Event
    August 3, 2004
    Report Date
    September 7, 2004
    Manufacturer
    COOK, INC.
    Product Code
    FEW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE, WHICH WAS PLACED FOR DRAINAGE OF A SUBDIAPHRAGMATIC ABSCESS, WAS REMOVED WITH A .035 RADIFOCUS AND WITHOUT USING A STYLET AT POST-OP DAY FIVE. THE PHYSICIAN STATED THAT HE FELT NO RESISTANCE DURING REMOVAL, HOWEVER, UPON REMOVAL, NOTED THE BLUE TIP OF THE CATHETER MISSING. THE FRAGMENT TIP WAS OBSERVED IN THE SUBDIAGPHRAGMATIC REGION. AN INCISION WAS MADE AND THE FRAGMENTED TIP WAS REMOVED VIA FORCEPS. HOWEVER, THIS RESULTED IN THE DEVELOPMENT OF PENUMOTHORAX, NECESSITATING PLACEMENT OF ANOTHER DRAINAGE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALECOT CATHETER CATHETER FEW COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention