inforMED
MalfunctionQKL

LIPOASPIRATE WASH SYSTEM

Received Jul 13, 2026 · Event occurred Jun 11, 2026

Report 1651189-2026-10903 · MDR key 25807264

Device

Generic name

Fat Transfer

Model number

VIALITY-1400

Catalog number

VIALITY-1400

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

FIRST VIALITY UNIT LINKED EXCESSIVELY. AN ADDITIONAL UNIT WAS REQUIRED.