SERANOVA MICRO INFUSION SYSTEM
Received Jun 1, 2026 · Event occurred May 18, 2026
Report MW5188822 · MDR key 25351128
Device
Generic name
Guide, Needle, Surgical
Manufacturer
Zhengzhou Magique Huaer Biotech Co.,ltd.Patient
55 YR · Female
- Erythema
- Itching Sensation
- Urticaria
- Swelling/ Edema
- Dry Skin
Narrative
Description of Event or Problem
I PURCHASED THE PRODUCT "SERANOVA MICRO INFUSION FOR SKIN CARE, HYDRATING FACIAL ESSENCE, FACIAL SERUM FOR SMOOTH SKIN FOR ALL SKIN TYPES, ONE MONTH SUPPLY" THROUGH AMAZON ON (B)(6) 2026, AND IT WAS DELIVERED ON (B)(6) 2026. I FIRST USED THE PRODUCT AROUND MY BIRTHDAY ON (B)(6) 2026. I APPLIED IT TO MY FACE AND ALSO TO MY HANDS, AS THE PRODUCT INSTRUCTIONS SUGGESTED IT COULD BE USED ON THE HANDS AS WELL. AFTER THE FIRST APPLICATION, MY FACE BECAME RED, BUT I BELIEVED THIS WAS A NORMAL REACTION BECAUSE THE PRODUCT INFORMATION INDICATED THAT REDNESS COULD OCCUR FOR SEVERAL HOURS AND THEN DISAPPEAR. HOWEVER, A FEW HOURS LATER, I STARTED EXPERIENCING ITCHING ON MY HANDS, ALONG WITH SMALL SKIN ERUPTIONS AND IRRITATION. I DID NOT GIVE MUCH IMPORTANCE TO THE SYMPTOMS BECAUSE THEY DISAPPEARED AFTER APPROXIMATELY TWO DAYS. AT THAT TIME, I DID NOT ASSOCIATE THE REACTION WITH THE PRODUCT AND THOUGHT IT COULD HAVE BEEN RELATED TO SWEATING OR ANOTHER EXTERNAL FACTOR. ON SUNDAY, (B)(6) 2026, I USED THE SECOND CAPSULE INCLUDED WITH THE PRODUCT. AGAIN, I APPLIED IT TO MY FACE AND USED THE REMAINING PRODUCT ON MY HANDS. AFTER THE SECOND USE, MY SYMPTOMS BECAME SIGNIFICANTLY WORSE AND HAVE PERSISTED. FROM (B)(6) 2026, I EXPERIENCED SEVERE AND CONTINUOUS ITCHING THAT DID NOT STOP. MY SKIN TEXTURE BECAME VERY DRY AND ROUGH. SMALL ERUPTIONS INITIALLY APPEARED, FOLLOWED BY SWELLING, REDNESS, DRYNESS, AND VISIBLE CHANGES IN SKIN TEXTURE. THE ITCHING BECAME INTENSE AND PERSISTENT. I ALSO CONTACTED SERANOVA REGARDING THIS ISSUE AND SUBMITTED A COMPLAINT DESCRIBING MY SYMPTOMS. I WAS INFORMED THAT SOMEONE WOULD CONTACT ME REGARDING MY CASE; HOWEVER, AS OF TODAY, I HAVE NOT RECEIVED ANY FOLLOW-UP COMMUNICATION. MY SYMPTOMS ARE CONTINUING AND HAVE NOT IMPROVED. THE ITCHING HAS NOT STOPPED SINCE SUNDAY, (B)(6) 2026, AFTER MY SECOND USE OF THE PRODUCT. THE REDNESS REMAINS PRESENT, AND THE TEXTURE OF MY SKIN HAS CHANGED SIGNIFICANTLY. MY SKIN BECAME DRY, IRRITATED, AND ROUGH, AND THE PERSISTENT ITCHING CONTINUES TO CAUSE SIGNIFICANT DISCOMFORT.