BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZZZ

    MDR report key: 6671271 · Received June 27, 2017

    Report

    Report Number
    3012316249-2017-00072
    Event Type
    Injury
    Date Received
    June 27, 2017
    Date of Event
    June 2, 2017
    Report Date
    June 27, 2017
    Manufacturer
    HSINER CO., LTD.
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER HAD RASHES OVER FACE AND BACK OF HEAD FROM FULL FACE CPAP MASK WITH HEADGEAR. HE HAD TO RECEIVE A STEROID SHOT AND MEDICATION TO TREAT THE ALLERGIC REACTION. THE CUSTOMER IS REPORTED AS AN EXPERIENCED CPAP USER. THE CUSTOMER HAD USED THIS MASK FOR 3 NIGHTS, AND DEVELOPED A SEVERE RASH NEAR HIS EYES, AND ON THE BACK OF HIS HEAD - HE WENT TO A CLINIC AND RECEIVED A STEROID SHOT. THE CUSTOMER REPORTS THAT THE CLINIC FEELS THE RASH WAS CAUSED BY THE HEADGEAR, AND NOT BY THE CUSHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451922 ZZZ CPAP MASK BZD HSINER CO., LTD. PB7800L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R