LIPOASPIRATE WASH SYSTEM
Received Jul 15, 2026 · Event occurred Jun 25, 2026
Report 1651189-2026-10915 · MDR key 25829803
Device
Generic name
Fat Transfer
Manufacturer
Tiger Aesthetics MedicalModel number
VIALITY-1400Catalog number
VIALITY-1400
Lot number
WO824
Product problems
- Leak/Splash
- Suction Problem
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. SIENTRA WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE HEALTHCARE PROVIDER REPORTED THAT THE VIALITY UNIT HAD NO SUCTION WHEN THE PROCEDURE STARTED AND LEAKING AT THE BOTTOM OF THE DEVICE. A NEW VIALITY UNIT WAS REQUIRED TO COMPLETE THE PROCEDURE.