BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 11655609 · Received April 13, 2021

    Report

    Report Number
    1810909-2021-00170
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 15, 2021
    Report Date
    March 15, 2021
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    JJX
    PMA / PMN Number
    K062058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER THE CONTOUR CONTROL SOLUTION SAFETY DATA SHEET, THE MATERIAL IN THE CONTOUR CONTROL SOLUTION IS NOT A HAZARDOUS SUBSTANCE. AS PER THE TOXICOLOGICAL INFORMATION ON THE SAFETY DATA SHEET, THE CONTACT OF THE CONTROL SOLUTION WITH THE EYE MAY CAUSE SLIGHT IRRITATION. 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 PATIENT/FAMILY WAS THE INITIAL REPORTER, SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED. SINCE NO PRODUCT DETAILS WERE PROVIDED, NO INFORMATION WAS CAPTURED FOR 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 CONTROL SOLUTION TO HER EYE. THE CUSTOMER STATED THAT SHE WAS IN A NURSING HOME WHERE A NURSE HELPED HER WASH HER EYES UPON THE DOCTOR'S INSTRUCTIONS. THE CUSTOMER DID NOT ALLEGE ANY SERIOUS EFFECTS. NO FURTHER EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555016 CONTOUR QUALITY CONTROL MATERIAL JJX ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR