BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MADAJET XL

    MDR report key: 6871735 · Received September 18, 2017

    Report

    Report Number
    2225311-2017-00001
    Event Type
    Injury
    Date Received
    September 18, 2017
    Date of Event
    May 27, 2014
    Report Date
    July 28, 2017
    Manufacturer
    MADA MEDICAL PRODUCTS, INC.
    Product Code
    EGM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MADA LEARNED OF A POSSIBLE SERIOUS INJURY INVOLVING A MADAJET WHEN IT WAS SERVED WITH A LAWSUIT BROUGHT BY THE PATIENT AGAINST HER TREATING PHYSICIAN AND MADA ON (B)(6) 2017. INITIAL DISCOVERY PROVIDED TO MADA IN CONNECTION WITH THE LAWSUIT INDICATED THAT THE NEEDLE FREE INJECTOR THAT WAS INVOLVED IN THE PATIENT'S INJURIES WAS A DERMOJET, WHICH IS NOT A MADA PRODUCT. HOWEVER, ON 6/26/2017, AT THE INSPECTION OF THE TREATING PHYSICIAN'S NEEDLE-FREE INJECTORS, THE TREATING PHYSICIAN PRESENTED A MADAJET RATHER THAN A DERMOJET. SINCE DISCOVERY IS CURRENTLY UNDERWAY IN THE LAWSUIT, MADA DOES NOT YET HAVE ALL AVAILABLE DATA.

    Description of Event or Problem · 1

    PER PATIENT'S LAWSUIT, ON (B)(6) 2014, PATIENT UNDERWENT LOWER LID BLEPHAROPLASTY, BROW/FOREHEAD LIFT AND DERMAL GRAFTS. ON (B)(6) 2014, PATIENT PRESENTED WITH A SCAR OF THE CENTRAL UPPER PORTION OF THE LOWER RIGHT EYELID. A NEEDLE-FREE INJECTOR WAS USED TO INJECT A STEROID (KENALOG) TO TREAT THE SCAR. THEREAFTER, PATIENT COMPLAINED OF VISUAL LOSS AND BLURRINESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652537 MADAJET XL NEEDLE FREE INJECTOR EGM MADA MEDICAL PRODUCTS, INC. 401

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability