BEUDAMED
    FDA Adverse Event Summary report: N

    SUGITA

    MDR report key: 91640 · Received February 15, 1995

    Report

    Report Number
    91640
    Date Received
    February 15, 1995
    Date of Event
    October 19, 1994
    Report Date
    December 6, 1994
    Manufacturer
    SIMS SURGICAL INC
    Product Code
    HCH
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AFTER PLACING A CLIP, THE PHYSICIAN ATTEMPTED TO REPOSITION THE CLIP. WHILE REPOSITIONING, THE CLIP SPRUNG OPEN, RIPPING THE NECK OF THE ANEURYSM. UNCONTROLLED BLEEDING OCCURRED UNTIL THE PHYSICIAN COULD PLACE ANOTHER ANEURYSM CLIP. PT WITH HEMIPLEGIA AND ALTERED LEVEL OF CONSCIOUSNESS POST-OEPRATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUGITA Implant ANEURYSM CLIP HCH SIMS SURGICAL INC 07-940-42 UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR