BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI CUSTOMEYES KIT

    MDR report key: 15759230 · Received November 9, 2022

    Report

    Report Number
    15759230
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 17, 2022
    Report Date
    October 19, 2022
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC
    Product Code
    PZG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LOOKING THRU CATARACT PACK OUTER PACKAGING YOU CAN SEE TEARS IN THE INNER DRAPE. WHICH COULD BE A SIGN OF POSSIBLE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296008 BVI CUSTOMEYES KIT SURGICAL EYE TRAY PZG BEAVER-VISITEC INTERNATIONAL, INC 584685 6048597

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown