BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT LT FOR HER MASK SYSTEM - USA

    MDR report key: 1780879 · Received July 30, 2010

    Report

    Report Number
    3004604967-2010-00032
    Event Type
    Injury
    Date Received
    July 30, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 29, 2010
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K073638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE PT ATTEMPTED TO REMOVE THE MASK FROM HER FACE, SHE SCRATCHED THE SCLERA ON HER RIGHT EYE. THE PT REPORTED THE SCRATCH WAS CAUSED BY THE MASK HEADGEAR. THE PT WAS SEEN BY HER EYE DOCTOR AND WAS PROVIDED EYE DROPS TO TREAT THE INJURY. THE PRODUCT WAS DISPOSED OF AND WILL NOT BE RETURNED TO RESMED FOR FURTHER EVAL.

    Description of Event or Problem · 1

    A DME REPORTED THAT A PT OBTAINED A SCRATCH TO THEIR EYE WHILE REMOVING THEIR CPAP MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT LT FOR HER MASK SYSTEM - USA BZD RESMED LTD. 60588

    Patients

    Seq Age Sex Outcome Treatment
    1 Other