FDA Adverse Event
Malfunction
Summary report: N
LIPOASPIRATE WASH SYSTEM
MDR report key: 23485872
·
Received November 6, 2025
Report
- Report Number
- 1651189-2025-09758
- Event Type
- Malfunction
- Date Received
- November 6, 2025
- Date of Event
- October 1, 2025
- Report Date
- October 13, 2025
- Manufacturer
- TIGER AESTHETICS MEDICAL
- Product Code
- QKL
- PMA / PMN Number
- BK190433
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
TIGER AESTHETICS MEDICAL COMPLAINT #: (B)(4). DEVICE EVALUATION: G3, G6, H2, H3, H6, H10. TIGER AESTHETICS MEDICAL PERFORMED AN EVALUATION FROM A DIFFERENT BATCH/LOT#. THE REPORTED CONDITION OF NO SUCTION REPORTED COULD NOT BE CONFIRMED. NO CAUSE COULD BE DETERMINED FOR THE REPORTED PROBLEM. TIGER AESTHETICS MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 0
TIGER AESTHETICS MEDICAL COMPLAINT #: (B)(4). 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 · 0
THE VIALITY SYSTEM WOULD NOT HOLD ANY SUCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121910 | LIPOASPIRATE WASH SYSTEM | FAT TRANSFER | QKL | TIGER AESTHETICS MEDICAL | VIALITY-1400 | A58634 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |