BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISORB EF MULTI-ABSORBER, DISPOSABLE

    MDR report key: 9849713 · Received March 18, 2020

    Report

    Report Number
    3002807637-2020-00002
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    January 1, 2020
    Report Date
    February 17, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF NOW, SAMPLES HAVE NOT BEEN RETURNED FOR EVALUATION. THERE ARE FOUR(4) LOT NUMBERS AFFECTED: 7961019, 4990819, 5120819 AND 8291019. ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE M1173311 MEDISORB EF MULTI-ABSORBER, DISPOSABLE GRANULES IN CANNISTERS ARE NOT ALLOWING WATER/MOISTURE TO DESCEND DOWN INTO THE CANISTER. NO HARM REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311294 MEDISORB EF MULTI-ABSORBER, DISPOSABLE CO2 ABSORBERS CBL VYAIRE MEDICAL MEDISORB¿ EF MULTI-ABSORBER, DISPOSABLE

    Patients

    Seq Age Sex Outcome Treatment
    1