BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUGITA ANEURYSM CLIP

    MDR report key: 17850 · Received September 20, 1994

    Report

    Report Number
    17850
    Event Type
    Injury
    Date Received
    September 20, 1994
    Date of Event
    August 16, 1994
    Report Date
    August 16, 1994
    Manufacturer
    SIMS SURGICAL, INC.
    Product Code
    HCH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT HAD SURGERY ON 8/11/94 FOR CLIPPING OF LEFT OPHTHALMIC ARTERY ANEURYSM. THREE ANEURYSM CLIPS WERE IMPLANTED AT THAT TIME. THE PT WAS RETURNED TO SURGERY ON 8/16/94 BECAUSE ONE OF THE ANEURYSM CLIPS HAD COME OFF AND HAD TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUGITA ANEURYSM CLIP Implant ANEURYSM CLIP HCH SIMS SURGICAL, INC. 05-23

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| L| R