BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMFORTGEL FULL FACE MASK

    MDR report key: 1243733 · Received November 25, 2008

    Report

    Report Number
    2518422-2008-00030
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 29, 2008
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K073600
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE MFR CAN NOT DETERMINE THE ROOT CAUSE OF THE REPORTED INJURY, BASED ON AVAILABLE INFO, IT IS CONCLUDED THAT THE PROBABILITY OF THE REPORTED EVENT RECURRING IS REMOTE AND THAT NO FURTHER ACTION IS APPROPRIATE.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER REPORTED TO THE MFR THAT A CUSTOMER ALLEGED LACERATING A FINGER WHILE REMOVING A COMFORTGEL FULL FACE MASK. THE CUSTOMER REPORTED SUTURES WERE REQUIRED TO THEIR INDEX FINGER. THE DME SUPPLIER STATED THE CUSTOMER IS AN ELDERLY PERSON WITH FRAGILE SKIN. THE DME SUPPLIER ALSO STATED THAT THE CUSTOMER COULD NOT IDENTIFY THE SPECIFIC SURFACE OF THE MASK ASSEMBLY THAT MADE CONTACT WITH THEIR SKIN WHEN THE INJURY OCCURRED, OR HOW THE LACERATION OCCURRED. THE MASK WAS RETURNED TO THE MFR FOR EVALUATION. EVALUATION OF THE MASK ASSEMBLY REVEALED IT CONFORMED TO DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS FREE OF SHARP EDGES ON EXPOSED EXTERNAL SURFACES AND PINCH POINTS WHICH COULD CONTRIBUTE TO A SKIN INJURY. A REVIEW OF THE MFR'S COMPLAINT DATABASE FROM THE PRODUCT'S RELEASE DATE 05/13/2008 TO 10/30/2008 REVEALED NO COMPLAINTS ALLEGING CUTS TO SKIN AS A RESULT OF THE PRODUCT'S USAGE, CARE AND OR HANDLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMFORTGEL FULL FACE MASK VENTILATOR, NON CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC. 1040142

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention