BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 10646378 · Received October 7, 2020

    Report

    Report Number
    1000125279-2020-00026
    Event Type
    Injury
    Date Received
    October 7, 2020
    Date of Event
    September 9, 2020
    Report Date
    September 9, 2020
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NEW WORLD MEDICAL (NWM) REVIEWED A SOCIAL MEDIA POST ON SEPTEMBER 9, 2020, USER INDICATED THAT A BULGE WAS PRESENT WHERE A POSSIBLE NWM DEVICE WAS IMPLANTED. NWM IS UNABLE TO DETERMINE WHETHER THE DEVICE IMPLANTED WAS MANUFACTURED BY THE COMPANY. NO SPECIFICS OF THE ISSUE REPORTED CAN BE DETERMINED AS CUSTOMER INFORMATION WAS NOT PROVIDED FOR FOLLOW UPS. NO INFORMATIN PROVIDED ON DEVICE IMPLANTED, LOT NUMBER NOR SERIAL NUMBER.

    Description of Event or Problem · 1

    ON NEW WORLD MEDICAL (NWM)'S SOCIAL MEDIA PLATFORM, A USER CREATED A POST , IN WHICH IT WAS INDICATED A BULGE IS PRESENT WHERE THE DEVICE HAS BEEN IMPLANTED. 3 WEEKS POST-OP, USER CLAIMED THAT VISION IS WORSE THAN BEFORE THE DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104960 UNKNOWN UNKNOWN KYF NEW WORLD MEDICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other