BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCS ANCHORS

    MDR report key: 320087 · Received March 13, 2001

    Report

    Report Number
    1221934-2001-00015
    Event Type
    Injury
    Date Received
    March 13, 2001
    Date of Event
    September 24, 1999
    Report Date
    March 13, 2001
    Manufacturer
    MITEK
    Product Code
    JDR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT RETURNED POST ANCHOR IMPLANT WITH SWELLING, REDNESS, SCARRING, AND CELLULITIS. PATIENT HAD A PRIOR HISTORY OF ALLERGIES. SUTURE WAS REMOVED AND ANCHORS LEFT IN PLACE. PATIENT CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11208 ARCS ANCHORS MINI QUICK JDR MITEK 212266 990799

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention