BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MADAJET XL

    MDR report key: 347870 · Received August 7, 2001

    Report

    Report Number
    MW4003067
    Event Type
    Injury
    Date Received
    August 7, 2001
    Date of Event
    April 1, 2001
    Report Date
    August 7, 2001
    Manufacturer
    MADA MEDICAL PRODUCTS, INC.
    Product Code
    EGM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NEWLY PURCHASED SUBCUTANEOUS NEEDLE-LESS INJECTION SYSTEM FOR DENTAL USE WAS TRIED (WITH LIDOCAINE) BY DENTIST ON THE FLESHY PART OF PALM PRIOR TO USING ON CHILDREN DENTAL PTS. COMPLAINANT EXPERIENCED IMMEDIATE SEVERE PAIN AND SWELLING AND STILL HAS PAIN IN ARM 4 MONTHS AFTER THE EPISODE. DENTIST DOESN'T THINK THAT THIS IS A DEVICE THAT SHOULD BE USED IN CHILDREN'S MOUTHS. MFR TOLD DENTIST THAT THERE IS NOTHING WRONG WITH THE DEVICE AND THAT THEY PROBABLY HIT A BONE WHEN THEY TRIED IT ON THEIR HAND. WHEN NOT AGAINST ANY OBJECT, THE DEVICE WILL EJECT A LIQUID UP TO 8 FEET WHEN ACTIVATED. UNIT HAS BEEN RETURNED TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36124 MADAJET XL SUBCUTANEOUS NEEDLELESS INJECTION SYSTEM EGM MADA MEDICAL PRODUCTS, INC. NA 011690XLD

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO LIDOCAINE