BEUDAMED
    FDA Adverse Event Other Summary report: N

    SLEEPNET

    MDR report key: 2466204 · Received November 7, 2011

    Report

    Report Number
    1424490-2011-00001
    Event Type
    Other
    Date Received
    November 7, 2011
    Date of Event
    October 4, 2011
    Report Date
    October 4, 2011
    Manufacturer
    CAREFUSION 211, INC.
    Product Code
    BZD
    PMA / PMN Number
    K060273
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). NOTE: CAREFUSION 205 INC. PURCHASES THIS DEVICE FROM SLEEPNET CORPORATION AND THEN SELLS THE DEVICE TO LOCAL DISTRIBUTORS. NEITHER THE END USER/PATIENT NOR CPAP SUPPLY USA SUBMITTED A USER FACILITY/IMPORTER REPORT TO CAREFUSION (TIARA) INC. EVENT CODES WERE DERIVED BASED ON INFORMATION DOCUMENTED BY A CAREFUSION (TIARA) INC. CUSTOMER SERVICE REP. IN RESPONSE TO A PHONE CONVERSATION WITH THE CPAP SUPPLY USA'S REPRESENTATIVE. (B)(4) (ALLEGED TO HAVE CAUSED ALLERGIC REACTION). THIS DEVICE IS NOT MANUFACTURED BY CAREFUSION. CAREFUSION WILL SEND A COPY OF THIS MEDWATCH REPORT TO THE MANUFACTURER AND ASK IF THEY WOULD LIKE THE DEVICE RETURNED TO THEM FOR EVALUATION.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION CONCERNING THE EVENT AND THE CONDITION OF THE PATIENT/END USER WAS DOCUMENTED BY A CAREFUSION (TIARA) CUSTOMER SERVICE REP. IN RESPONSE TO A PHONE CONVERSATION WITH THE DISTRIBUTOR'S REPRESENTATIVE. "PATIENT RECEIVED MASK ON (B)(6) 2011 AND CALLED ON (B)(6) 2011 TO REPORT HE HAD AN ALLERGIC REACTION AROUND HIS NOSE AND MOUTH. WE ARE SENDING A REPLACEMENT AND A RETURN LABEL ON (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEPNET CPAP MASK BZD CAREFUSION 211, INC. MOJO FULL FACE MASK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other