BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADRENACLICK

    MDR report key: 25121794 · Received May 8, 2026

    Report

    Report Number
    3002919960-2026-00013
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Report Date
    May 19, 2026
    Manufacturer
    PHILLIPS-MEDISIZE LLC
    Product Code
    PQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

    Description of Event or Problem · 0

    THE EPINEPHRINE DID NOT DISPENSE [DEVICE FAILURE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER, AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON (B)(6)2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM PATIENT VIA AN EMAIL CONCERNING ABOVE-MENTIONED EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S EPINEPHRINE AUTOINJECTOR. THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTOINJECTOR (STRENGTH, DOSE, FREQUENCY, ROUTE AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. CONCURRENT CONDITION, CO-SUSPECT MEDICATION, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES AND SURGERIES, HISTORICAL DRUG AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED, THE PATIENT RECENTLY NEEDED FOR THE EPINEPHRINE INJECTOR AND THE EPINEPHRINE AUTO-INJECTOR FAILED. THEY DISPENSED A SECOND AUTOINJECTOR IN DESPERATION, LATER IT WAS DISCOVERED THAT THE EPINEPHRINE DID NOT DISPENSE. LAST ACTION TAKEN WITH EPINEPHRINE AUTOINJECTOR IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WITH EPINEPHRINE AUTOINJECTOR. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579893 ADRENACLICK TYPE 2 PQX PHILLIPS-MEDISIZE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other