BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTO SUTURE MINISITE 2MM

    MDR report key: 136083 · Received December 2, 1997

    Report

    Report Number
    1219161-1997-01802
    Event Type
    Injury
    Date Received
    December 2, 1997
    Date of Event
    November 25, 1997
    Report Date
    November 25, 1997
    Manufacturer
    IMAGYN MEDICAL INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DISTRIBUTOR HAS RECEIVED ADDITIONAL INFO STATING NO DAMAGE OR UNANTICIPATED TISSUE LOSS HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE MINISITE 2MM REUSABLE LAPAROSCOPE GCJ IMAGYN MEDICAL INC. 171303 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention