BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT BAND

    MDR report key: 2327430 · Received November 4, 2011

    Report

    Report Number
    2327430
    Event Type
    Malfunction
    Date Received
    November 4, 2011
    Date of Event
    October 1, 2011
    Report Date
    November 4, 2011
    Manufacturer
    TZ MEDICAL, INC
    Product Code
    MHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR DID A RADIAL CASE AND POST PROCEDURE ASKED FOR A COMFORT BAND. THE NURSE GAVE HIM THE COMFORT BAND FROM LAB 2 STOCK. (B)(4). HE REMOVED THE SHEATH AND APPLIED THE BAND TO THE PATIENT'S WRIST. HE STATED HE NEEDED A NEW BAND DUE TO THIS ONE BENDING IN THE MIDDLE PORTION THAT GOES OVER THE ARTERIAL SITE. THE NURSE RETRIEVED ANOTHER BAND. THE DOCTOR SAID HE PREFERS THIS ONE. (B)(4). THE TWO BANDS LOOK THE SAME EXCEPT FOR A CREASE IN THE MIDDLE OF THE BAND THAT GOES OVER ARTERIAL SITE. HE STATED THAT THE FIRST ONE DOES NOT HOLD THE SITE WELL ENOUGH FOR HEMOSTASIS. THE SECOND BAND WAS APPLIED. THE DOCTOR DOESN'T CARE FOR THE NEW DESIGN. THE OLD DESIGN IS NO LONGER AVAILABLE FOR PURCHASE. WE ARE INVESTIGATING OTHER OPTION TO OFFER THE DOCTOR. THE PATIENT WAS WITHOUT BLEEDING OR DISCOMFORT IN RIGHT WRIST. NO HARM DONE TO PATIENT.THE DOCTOR DIDN'T CARE FOR THE FIRST BAND DUE TO IT BENDING IN THE MIDDLE PORTION THAT GOES OVER THE ARTERIAL SITE AND DOES NOT HOLD AS GOOD, SO THEY CHANGE TO (B)(4) WHICH DOES A BETTER JOB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMFORT BAND COMFORT BAND MHW TZ MEDICAL, INC * CB-A0201B

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR