BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPAP CHIN STRAP

    MDR report key: 3308596 · Received August 23, 2013

    Report

    Report Number
    MW5031583
    Event Type
    Injury
    Date Received
    August 23, 2013
    Report Date
    August 23, 2013
    Manufacturer
    AG INDUSTRIES
    Product Code
    LRK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    THE CALLER WHO IS A MEDICAL STUDENT AT (B)(4) HOSPITAL REPORTS THAT ONE OF HIS PTS SUFFERING FROM OBSTRUCTIVE SLEEP APNEA RECEIVED A NEW MASK FOR HER C-PAP MACHINE. SHE USED THIS MASK FOR ONE NIGHT AND WOKE UP WITH CONTACT DERMATITIS. THIS AFFECTED THE SKIN AROUND HER MOUTH, MANDIBLE AND ALL THE WAY TO BEHIND HER EARS. THE PT IS ALLERGIC TO LATEX AND WAS WONDERING IF THE NEW MASK CONTAINS LATEX PRODUCTS WHICH COULD BE THE COST OF THE DERMATITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412511 CPAP CHIN STRAP CPAP CHIN STRAP LRK AG INDUSTRIES 041513

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR