MalfunctionQKL
LIPOASPIRATE WASH SYSTEM
Received Jul 1, 2026 · Event occurred Jun 9, 2026
Report 1651189-2026-10831 · MDR key 25677670
Device
Generic name
Fat Transfer
Manufacturer
Tiger Aesthetics MedicalModel number
VIALITY-1400Catalog number
VIALITY-1400
Lot number
A60538
Product problems
- Leak/Splash
Patient
99 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE VIALITY UNIT HAD MAJOR LEAKING AND THE MAYO STAND WAS SOAKING WET. AN ADDITIONAL VIALITY UNIT WAS USED.
Additional Manufacturer Narrative
TIGER AESTHETICS MEDICAL COMPLAINT #: (B)(4). PATIENT AGE DEFAULTED TO "99" AS NO PATIENT INFORMATION 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.