BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHETIC EYE

    MDR report key: 22028173 · Received May 15, 2025

    Report

    Report Number
    MW5170425
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    June 11, 2024
    Report Date
    October 18, 2025
    Manufacturer
    KOLBERG OCULAR PRODUCTS INC.
    Product Code
    HQH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6), PROSTHETIC EYE MADE BY (B)(4) KOLBERG OCULAR PRODUCTS CAUSING ELECTROCUTION IN (B)(6) ON (B)(6) 2024 AT (B)(6) HOSPITALIZED AT (B)(6) HOSPITAL APPOINTMENT DATES (B)(6) 2024.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE REPORTER ON 10/22/2025 FOR A REPORT #MW5170425. REFERRAL FROM DR (B)(6), (B)(6) 2024, (B)(6). MEDICATED MEDICAL DEVICE TO PREVENT PTSD AND TO GIVE A BETTER APPEARANCE. (B)(6) PROSTHETIC EYE MADE BY (B)(6) ON (B)(6) 2024 AT (B)(6). HOSPITALIZED AT (B)(6). [(B)(6) MALPRACTICE] APPOINTMENT DATES (B)(6) 2024. (B)(6) /OCULARIST IS A SPECIALLY TRAINED TECHNICIAN WHO WORKS WITH DOCTORS AS PART OF A PATIENT HEALTH CARE. HE'S CONTRACTED WITH (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2190891 PROSTHETIC EYE EYE, ARTIFICIAL, NON-CUSTOM HQH KOLBERG OCULAR PRODUCTS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Life Threatening| H