BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AHMED CLEARPATH

    MDR report key: 18688653 · Received February 12, 2024

    Report

    Report Number
    1000125279-2024-00007
    Event Type
    Injury
    Date Received
    February 12, 2024
    Date of Event
    January 14, 2024
    Report Date
    February 12, 2024
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    PMA / PMN Number
    K182518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WAS INSTRUCTED TO COMMUNICATE WITH THEIR PHYSICIAN REGARDING OUTCOMES AND EXPECTATIONS FOR SURGERY. PHYSICIAN WILL CONTACT NWM FOR ADDITIONAL INFORMATION OR CONCERNS. NO SERIAL NUMBER WAS PROVIDED FOR REVIEW OF PRODUCTION LOT DOCUMENTATION. NO DEVICE AVAILABLE FOR EVALUATION. NO ISSUES COULD BE CONFIRMED.

    Description of Event or Problem · 0

    PATIENT SUBMITTED REPORT THROUGH NEW WORLD MEDICAL CONTACT US PAGE. REPORTED PAIN FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086063 AHMED CLEARPATH GLAUCOMA DRAINAGE DEVICE KYF NEW WORLD MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other