SKINPEN PRECISION ELITE SYSTEM (POWERED MICRONEEDLE DEVICE)

Additional Manufacturer Narrative

THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

Description of Event or Problem

SYNCOPAL EPISODE UPON INITIATION OF OUR FIRST TREATMENT [SYNCOPE]. CASE NARRATIVE: UNITED STATES REPORT RECEIVED FROM HEALTH CARE PROFESSIONAL VIA A COMPANY REPRESENTATIVE ON 23-JUN-2026, REFERS TO A FEMALE PATIENT OF UNKNOWN AGE WHO HAD RECEIVED A SKINPEN PRECISION ELITE SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT ON (B)(6) 2026 FOR AN UNKNOWN INDICATION. THE PATIENT¿S MEDICAL HISTORY WAS NOT REPORTED. CONCOMITANT MEDICATIONS AND FOOD SUPPLEMENTS WERE NOT PROVIDED. THE EXACT TREATMENT DEPTH OF THE SKINPEN PRECISION ELITE SYSTEM (POWERED MICRONEEDLE DEVICE) WAS NOT REPORTED. #LOT AND EXPIRATION DATE WERE NOT PROVIDED. ON (B)(6) 2026, THE PATIENT EXPERIENCED A SYNCOPAL EPISODE UPON INITIATION OF THE FIRST TREATMENT. THERE WERE NO COMPLICATIONS RELATED TO THE PRODUCT OR DEVICE. AFTER THE PATIENT WAS STABILIZED, THE TREATMENT SESSION WAS COMPLETED WITHOUT FURTHER ISSUES. NO TREATMENT WAS ADMINISTERED SPECIFICALLY FOR THE SYNCOPAL EPISODE. THE PATIENT DID NOT UNDERGO ANY LABORATORY OR DIAGNOSTIC TESTS. AT THE TIME OF REPORT, THE OUTCOME OF THE EVENT SYNCOPAL ATTACK WAS RESOLVED. THE INTENSITY OF THE EVENT SYNCOPAL ATTACK WAS NOT REPORTED. IT WAS UNKNOWN IF THE SKINPEN PRECISION ELITE SYSTEM (POWERED MICRONEEDLE DEVICE) PRODUCT WAS AVAILABLE FOR RETURN. HEALTH EFFECT: CLINICAL CODE E011903, SYNCOPE/FAINTING. MEDDRA PREFERRED TERM: SYNCOPE. HEALTH EFFECT ¿ DEVICE CODE: A24, ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.