BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KITTNER -TIPPED ENDOSCOPIC STICK

    MDR report key: 1653433 · Received March 29, 2010

    Report

    Report Number
    1030451-2010-00002
    Event Type
    Malfunction
    Date Received
    March 29, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 2, 2010
    Manufacturer
    MEDICAL ACTION INDUSTRIES INC.
    Product Code
    KDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIRST COMPLAINT OF THIS TYPE FOR THIS PRODUCT.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE SPONGE CAME OFF AND FELL INTO THE ABDOMEN. IT WAS RETRIEVED; ANOTHER SPONGE WAS PULLED AND USED WITH NO PROBLEM. THE PATIENT DID NOT NEED ANY EXTENDED CARE DUE TO THIS. NO FURTHER CONSEQUENCES OR IMPACT TO THE PATIENT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KITTNER -TIPPED ENDOSCOPIC STICK ENDOSCOPIC KITTNER DISSECTOR KDC MEDICAL ACTION INDUSTRIES INC. E7500 080879

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention