ADRENACLICK

Description of Event or Problem

I COULDN'T GET THE NEEDLE TO SPRING OUT [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 MALE PATIENT (AGE, AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 04-MAY-2026, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM PATIENT VIA A VOICEMAIL CONCERNING ABOVE-MENTIONED EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S ADRENACLICK (EPINEPHRINE AUTO-INJECTOR). THE PATIENT WAS BEING TREATED WITH ADRENACLICK (EPINEPHRINE AUTO-INJECTOR) (STRENGTH, BATCH NO, EXPIRATION DATE, NDC, DOSE, AND FREQUENCY WERE NOT REPORTED) VIA AN INTRAMUSCULAR ROUTE FOR A REACTION TO SOMETHING. CONCURRENT CONDITION INCLUDED A REACTION TO SOMETHING. 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 THAT THE PATIENT HAD A REACTION TO SOMETHING AND HAD USED THE EPINEPHRINE AUTO-INJECTOR; HOWEVER, THE PATIENT COULD NOT GET THE NEEDLE TO SPRING OUT. LAST ACTION TAKEN WITH ADRENACLICK 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 ADRENACLICK. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.