MalfunctionQKL
LIPOASPIRATE WASH SYSTEM
Received Jun 10, 2026 · Event occurred May 26, 2026
Report 1651189-2026-10765 · MDR key 25461270
Device
Generic name
Fat Transfer
Manufacturer
Tiger Aesthetics MedicalModel number
VIALITY-1400Catalog number
VIALITY-1400
Lot number
A61428
Product problems
- Fluid/Blood Leak
Patient
99 YR · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
THE HEALTHCARE PROVIDER REPORTED THAT TWO VIALITY UNITS LEAKED. NEW VIALITY UNITS NEEDED TO BE OPENED TO FINISH THE PROCEDURE.
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. SIENTRA WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.