BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAVER-VISITEC INTERNATIONAL INC

    MDR report key: 19362768 · Received May 21, 2024

    Report

    Report Number
    1211998-2024-00011
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    February 9, 2024
    Report Date
    May 21, 2024
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL INC
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION COULD NO BE COMPLETED BECAUSE THERE WAS NO EVIDENCE OF THE "CONTAMINATION" SINCE NO SAMPLES OR PICTURES WERE PROVIDED BY CUSTOMER, ALSO THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. COMPLAINT WAS ACKNOWLEDGED BASED ON THE CUSTOMER'S INFORMATION.

    Description of Event or Problem · 0

    CUSTOMER ALLEGED THAT A FOREIGN MATERIAL HAS BEEN FOUND ON 27-GAUGE CANNULA. THE MATERIAL LEAVES A METALLIC-LIKE BLACK DEPOSIT INSIDE THE CORNEA WOUND THE BLACK DEPOSIT IS CAUSING INFLAMMATION INSIDE THE CORNEAL WOUND WHICH IS VISIBLE POST-OP DAY 1.

    Description of Event or Problem · 0

    CUSTOMER ALLEGED THAT A FOREIGN MATERIAL HAS BEEN FOUND ON 27-GAUGE CANNULA. THE MATERIAL LEAVES A METALLIC-LIKE BLACK DEPOSIT INSIDE THE CORNEA WOUND THE BLACK DEPOSIT IS CAUSING INFLAMMATION INSIDE THE CORNEAL WOUND WHICH IS VISIBLE POST-OP DAY 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155519 BEAVER-VISITEC INTERNATIONAL INC 585736 - CANN ANTERIOR CHAMBER 27G 7/8IN HMX BEAVER-VISITEC INTERNATIONAL INC 585736 6064256

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other