BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMOJET MODEL

    MDR report key: 8169556 · Received December 14, 2018

    Report

    Report Number
    MW5082169
    Event Type
    Injury
    Date Received
    December 14, 2018
    Date of Event
    November 7, 2018
    Report Date
    March 12, 2018
    Manufacturer
    ROBBINS INSTRUMENTS, INC.
    Product Code
    NSC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DERMOJET DEVICE IS USED TO INJECT LOCAL ANESTHETIC INTO DERMIS, AND IN THIS PATIENT IT INJECTED MINUTE PARTICLES OF A DETERIORATED ¿O¿ RING SEAL. SIX SEPARATE LOCATIONS WERE INJECTED, EACH OF THESE FORMED SMALL SUBCUTANEOUS NODULES, AND 4 OF THESE NODULES INFLAMED AND ENLARGED. THREE OF THESE PRODUCED ABSCESSES THAT WERE DETERMINED TO BE STERILE BASED ON TWO SEPARATE NEGATIVE CULTURES OF ASPIRATED FLUID. TWO OF THE NODULES ENLARGED TO APPROXIMATELY 1.2 CM X 1.2 CM AND WERE SURGICALLY EXERCISED AND SENT IN THEIR ENTIRETY TO PATHOLOGY. PATHOLOGY FINDINGS OF THE TWO EXCISED NODULES WERE BOTH REPORTED AS GRANULOMA, FIBROSIS AND CHRONIC INFLAMMATORY CELL INFILTRATES. THESE HAVE HEALED WITHOUT COMPLICATION. ONE NODULE DRAINED ON ITS OWN AND HAS RESOLVED. THE REMAINING NODULES APPEAR INFLAMED AND WE HAVE TAKEN A WATCH AND WAIT PLAN IN ANTICIPATION THAT THEY WILL DRAIN ON THEIR OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002956 DERMOJET MODEL INJECTOR, PEN NSC ROBBINS INSTRUMENTS, INC. G

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention