BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEPEASY

    MDR report key: 2539317 · Received April 12, 2012

    Report

    Report Number
    2518422-2012-00428
    Event Type
    Injury
    Date Received
    April 12, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 15, 2012
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K010263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVAL BY THE MFR. K052110.

    Description of Event or Problem · 1

    A PT ALLEGES HE HAD A REAR MOLAR EXTRACTED BY AN ORAL SURGEON AND REPLACED WITH A POST AND FALSE TOOTH BECAUSE HIS CONTINUOUS POSITIVE AIRWAY PRESSURE (BIPAP) THERAPY. THERE HAS BEEN NO REPORT OF DEVICE MALFUNCTION FOR THE CPAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEPEASY CPAP SYSTEM BZD RESPIRONICS INC. 1043237

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability MEDIUM, (B)(4)| COMFORTGEL BLUE NASAL MASK WITH HEADGEAR,