BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK GII ANCHOR

    MDR report key: 45630 · Received October 29, 1996

    Report

    Report Number
    1221934-1996-00002
    Event Type
    Injury
    Date Received
    October 29, 1996
    Date of Event
    August 23, 1996
    Report Date
    October 28, 1996
    Manufacturer
    MITEK SURGICAL PRODUCTS, INC.
    Product Code
    KGS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ANCHOR FOUND LOOSE AFTER STAMEY PROCEUDRE. THE ANCHOR WAS REMOVED IN A SECOND PROCEDURE. THE PT HAD DEVELOPED AND WAS TREATED FOR A BACTERIODED FRAGILIS INFECTION AT THE IMPLANT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK GII ANCHOR Implant SUTURE ANCHOR KGS MITEK SURGICAL PRODUCTS, INC. * 951269, 951287

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R