BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPASS HEALTH BRANDS

    MDR report key: 20828506 · Received December 2, 2024

    Report

    Report Number
    3011189029-2024-00001
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    June 3, 2020
    Report Date
    December 2, 2024
    Manufacturer
    DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIP.CO
    Product Code
    CAF
    UDI-DI
    00092237619803
    PMA / PMN Number
    3011189029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO DISTRIBUTORS REPORTING MDR DIRECTLY ON THE MAUDE DATA SYSTEM ON THE FDA OFFICIAL WEBSITE WITHOUT INFORMING THE SALES DEPARTMENT OF THE INFORMATI ON, THE SALES DEPARTMENT DID NOT REGULARLY COLLECT FEEDBACK INFORMATION FROM DISTRIBUTORS AND DID NOT REALIZE THE NEED TO PROACTIVELY CHECK WHETHER THE CO MPANY HAS MDR ON THE MAUDE DATA SYSTEM ON THE FDA OFFICIAL WEBSITE. THEY ONLY BELIEVED THAT ONLY INFORMATION DIRECTLY COMPLAINED TO OUR COMPANY BY CUST OMERS NEEDS TO BE PROCESSED, RESULTING IN THE COMPANY NOT BEING AWARE OF THIS MDR. THE MDR REPORT IS AS FOLLOWS: MDR REPORT #3012316249-2020-00032. LETTER OF REPRESENTATION RECEIVED:CLAIMANT SUSTAINED PERSONAL INJURIES AS THE RESULT OF AN INCIDENT, WHEREBY OUR CLIENT USED THE PRODUCT AND WAS BURNED.AS A RESULT OF THIS INCIDENT,A CLAIM IS BEING MADE AGAINST YOUR INSURED. RECEIVED A LETTER FROM THE REPRESENTATIVE: THE CLAIMANT SUFFERED PERSONAL INJURY DUE TO AN INCIDENT IN WHICH OUR CUSTOMER USED THE PRODUCT AND WAS BURNED. AS A RESULT OF THIS INCIDENT, A CLAIM IS BEING MADE AGAINST YOUR INSURED. MDR REPORT # 3012316249-2020-00032 OCCURRED IN 2020, AND NOW IT HAS EXPIRED. FOR DETAILS, PLEASE REFER TO CUSTOMER SURVEY RECORD FORM NO: (B)(4).

    Description of Event or Problem · 0

    LETTER OF REPRESENTATION RECEIVED: CLAIMANT SUSTAINED PERSONAL INJURIES AS THE RESULT OF AN INCIDENT, WHEREBY OUR CLIENT USED THE PRODUCT AND WAS BURNED.AS A RESULT OF THIS INCIDENT, A CLAIM IS BEING MADE AGAINST YOUR INSURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291094 COMPASS HEALTH BRANDS NEBULIZER CAF DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIP.CO NEB-RITE4 OR2361808-8 00092237619803

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Unknown Required Intervention