BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREFUSION

    MDR report key: 3883992 · Received June 11, 2014

    Report

    Report Number
    1424490-2014-00001
    Event Type
    Other
    Date Received
    June 11, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    CAREFUSION 211, INC.
    Product Code
    BTK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER/PATIENT DID NOT SUBMIT A USER FACILITY/IMPORTER REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFO PROVIDED BY THE END USER/PATIENT. (B)(4). THE PURESOM RUBY ADJUSTABLE CHINSTRAP HAS BEEN RECEIVED, ROUTED TO THE CAREFUSION FAILURE ANALYSIS LAB AND STAGED FOR EVALUATION. ONCE THE EVALUATION IS COMPLETED, A F/U MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN EMAIL WAS SENT TO SLEEP SUPPORT VIA THE CAREFUSION WEBSITE. IT READ: "I'M GUESSING THAT YOU HAVE CHANGED THE MANUFACTURING OF YOUR CHIN STRAP. I LOVED THE FIRST ONE I HAD, BUT IT GOT OLD AND SOMEWHAT FUZZY. THE NEW ONE ITCHED FROM THE FIRST DAY I WORE IT, ALMOST LIKE FIBERGLASS FIBERS IN MY CHIN. I WASHED IT SEVERAL TIMES AND IT WAS VERY SLIGHTLY BETTER. HOWEVER, NOW I HAVE A RASH FROM IT AND HAVE DISCONTINUED USING IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345929 CAREFUSION STRAP, HEAD, GAS MASK BTK CAREFUSION 211, INC. PURESOM RUBY ADJUSTABLE 011013A01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other