BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMO-JET MODEL G

    MDR report key: 8169557 · Received December 14, 2018

    Report

    Report Number
    MW5082170
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DERMOJET DEVICE IS USED TO INJECT LOCAL ANESTHETIC INTO DERMIS. IN THIS EVENT IT INJECTED MINUTE PARTICLES OF A DETERIORATED "O" RING INTO THE SKIN OF THE PT'S LOW BACK. APPROX SIX OF THESE INFLAMED AND BECAME NODULAR ABOUT 2 WEEKS AFTER THE INJECTION. THIS PT WAS MONITORED AND TREATED BY OTHER PHYSICIANS AND WAS INITIALLY THOUGHT TO HAVE A LOCALIZED INFECTION AND WAS TREATED WITH ANTIBIOTICS WITHOUT A CULTURE BEING OBTAINED. NODULES FORMED UNDER THE DERMIS, WHICH WERE SUBSEQUENTLY CULTURED AND BIOPSIED. CULTURES WERE NEGATIVE GROWTH FOR ANAEROBIC AND AEROBIC BACTERIA. PATHOLOGY WAS REPORTED AS THERE IS A SUPERFICIAL AND DEEP, PERIVASCULAR AND INTERSTITIAL, LYMPHOHISTIOCYTIC INFILTRATE WITH SCATTERED EOSINOPHILS AND OCCASIONAL NEUTROPHILS. SOME LYMPHOCYTES EXTEND TO THE OVERLYING EPIDERMIS WHERE THERE IS MILD ACANTHOSIS, SPONGIOSIS AND MILD BASAL VACUOLAR CHANGE. NEITHER FUNGI NOR ACID-FAST BACILLI ARE IDENTIFIED WITH PAS AND FITE STAINS, RESPECTIVELY. TREPONEMA, HSV AND VZV IMMUNOSTAINS ARE NEGATIVE. ADDITIONAL SECTIONS HAVE BEEN EXAMINED. NO POLARIZABLE FOREIGN MATERIAL IS IDENTIFIED WITH POLARIZED MICROSCOPY. THIS PATIENT SUBSEQUENTLY UNDERWENT MULTIPLE EXCISIONS OF THE NODULES ON SEPARATE OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006714 DERMO-JET MODEL G INJECTOR, PEN NSC ROBBINS INSTRUMENTS, INC. G

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention