LIPOASPIRATE WASH SYSTEM
Received Jun 22, 2026 · Event occurred Jun 17, 2026
Report 1651189-2026-10813 · MDR key 25580312
Device
Generic name
Fat Transfer
Manufacturer
Tiger Aesthetics MedicalModel number
VIALITY-1400Catalog number
VIALITY-1400
Lot number
WO656
Product problems
- Fluid/Blood Leak
Patient
99 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE HEALTHCARE PROVIDER REPORTED THAT THE VIALITY UNIT LOSS OF FAT THROUGH THE TRAY INTO THE WASTE CANNISTER. THIS WAS NOTICED AFTER THE CLAP WAS REMOVED TO SUCTION OUT FLUID AFTER AURACLENS. A NEW VIALITY UNIT WAS REQUIRED TO COMPLETE THE PROCEDURE.
Additional Manufacturer Narrative
TIGER AESTHETICS MEDICAL COMPLAINT #: (B)(4). PATIENT AGE DEFAULTED TO "99" AS NO PATIENT AGE WAS PROVIDED. AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. TIGER AESTHETICS MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.