BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOTECH PRODUCTS

    MDR report key: 11974562 · Received June 10, 2021

    Report

    Report Number
    2025917-2021-00005
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Report Date
    June 10, 2021
    Product Code
    BXJ
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED AND NO EVALUATION WAS POSSIBLE ON THE ACTUAL DEVICE. HOWEVER, SAMPLES OF FINISHED GOODS WERE PULLED OUT FROM RETAINED SAMPLES OF BOTH REPORTED AND CURRENT LOT NUMBERS FOR RE-INSPECTION AND NO ABNORMALITY WAS FOUND. ALSO, THE PRODUCT'S DEVICE HISTORY RECORDS (DHR) OF REPORTED LOT AND CURRENT INVENTORY WERE REVIEWED AND NO NONCONFORMITY WAS FOUND. PER OUR INVESTIGATION DEVICE WAS USED WITH RAM CANNULA AND ON OFF LABEL USE FOR CPAP. THIS COULD BE CONTRIBUTED TO THESE ISOLATED INCIDENTS AS WE JUST HAD ONE SIMILAR INCIDENT FROM THE SAME SOURCE IN THE PAST FIVE YEARS FOR MILLIONS OF THE PARTS THAT WERE USED ALL AROUND THE WORLD. PER COMPLAINTS RATIO, THESE INCIDENTS WERE ISOLATED EVENTS. THIS COMPLAINT WILL BE MONITORED FOR TRENDING PURPOSES AND IS ADDED TO THE RELATED LOGS AND CHARTS.

    Description of Event or Problem · 1

    PER CUSTOMER, NEOSEAL FOUND IN BABY'S MOUTH BUT WAS REMOVED IN TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869068 NEOTECH PRODUCTS NEOSEAL BXJ N422 2020-0813

    Patients

    Seq Age Sex Outcome Treatment
    1 Other