BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGLIN HOOK

    MDR report key: 225383 · Received May 27, 1999

    Report

    Report Number
    225383
    Event Type
    Injury
    Date Received
    May 27, 1999
    Date of Event
    May 19, 1999
    Report Date
    May 26, 1999
    Manufacturer
    UNK
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT TURNED HEAD AND MOVED ON THE BED WHILE PHACO HANDPIECE WITH ATTACHED KUGLIN HOOK IN RIGHT EYE, YET NOT TURNED ON. BLEEDING NOTED. IOL IMPLANT COMPLETED. IMMEDIATELY POST-OPERATIVELY PT COMPLAINED OF EYE. LOSS OF VISION PERSISTS. RETURNED TO SURGERY 05/25/1999 FOR EVACUATION OF HYPHEMA RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGLIN HOOK PHACO HAND-PIECE & DISPOSABLE KUGLIN HOOK HQC UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R