BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR NEXT

    MDR report key: 11772162 · Received May 4, 2021

    Report

    Report Number
    1810909-2021-00198
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    March 6, 2021
    Report Date
    April 8, 2021
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    JJX
    PMA / PMN Number
    K151742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER THE CONTOUR NEXT CONTROL SOLUTION SAFETY DATA SHEET, THE MATERIAL IN THE CONTOUR NEXT CONTROL SOLUTION IS NOT A HAZARDOUS SUBSTANCE. IN THE CASE OF CONTACT WITH EYES, THE SAFETY DATA SHEET ADVISES RINSING EYES IMMEDIATELY WITH PLENTY OF WATER AND TO SEEK MEDICAL ADVICE. THE CUSTOMER WASHED THEIR EYE WITH WATER AND INDICATED THAT SHE HAS AN APPOINTMENT WITH HER DOCTOR DUE TO HER EYES BEING IRRITATED. THE PATIENT/FAMILY WAS THE INITIAL REPORTER, SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED. SINCE NO PRODUCT DETAILS WERE PROVIDED, NO INFORMATION WAS CAPTURED (MODEL #, LOT #, AND EXPIRATION DATE), AND THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CALLED TO REPORT THAT SHE ACCIDENTALLY APPLIED THE CONTOUR NEXT CONTROL SOLUTION INTO HER EYE AFTER WHICH SHE HAD AN EYE IRRITATION. SHE WASHED HER EYES WITH WATER AND RECOVERED WELL. THE CUSTOMER DID NOT ALLEGE ANY SERIOUS EFFECTS. NO FURTHER EVENT DETAILS WERE PROVIDED. THE CUSTOMER DISCARDED THE VIAL OF THE CONTOUR NEXT CONTROL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669030 CONTOUR NEXT QUALITY CONTROL MATERIAL JJX ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR