BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELKER EMERGENCY CUFFED CRICOTHYROTOMY CATHETER SET

    MDR report key: 7372854 · Received March 27, 2018

    Report

    Report Number
    1820334-2018-00871
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    May 13, 2015
    Report Date
    March 27, 2018
    Manufacturer
    COOK INC
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: COMMON DEVICE NAME: JOH TUBE TRACHEOSTOMY AND TUBE CUFF. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS TRYING TO PERFORM A CRICOTHYROTOMY WITH THE MELKER EMERGENCY CUFFED CRICOTHYROTOMY CATHETER SET, BUT THE SCALPEL INCLUDED WITH THE KIT WAS NOT SHARP ENOUGH TO MAKE THE PROPER INCISION. HOWEVER, IT WAS ALSO STATED THAT THE PATIENT HAD TOUGH/THICK SKIN. ANOTHER SCALPEL WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216504 MELKER EMERGENCY CUFFED CRICOTHYROTOMY CATHETER SET JOH COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR