MalfunctionQKL
LIPOASPIRATE WASH SYSTEM
Received Jul 8, 2026 · Event occurred Jul 1, 2026
Report 1651189-2026-10890 · MDR key 25750166
Device
Generic name
Fat Transfer
Manufacturer
Tiger Aesthetics MedicalModel number
VIALITY-1400Catalog number
VIALITY-1400
Lot number
A61652
Product problems
- Leak/Splash
Patient
99 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
VIALITY UNIT WAS LEAKING DURING THE CASE. A NEW VIALITY UNIT WAS REQUIRED TO COMPLETE THE PROCEDURE.