MAUDE Adverse Event Report: TIGER AESTHETICS MEDICAL LIPOASPIRATE WASH SYSTEM; FAT TRANSFER

Model Number	VIALITY-1400
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Tiger aesthetics medical complaint #: (b)(4).Patient age defaulted to "(b)(6)" 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.
Event or Problem Description
Two viality units had suction issues at the onset of the case.Backup was used to complete the procedure.The healthcare provider heard sounds like the seal is broken.
Additional Manufacturer Narrative
Tiger aesthetics medical complaint #: (b)(4).Device evaluation: g3, g6, h2, h3, h6, h10.This is a known issue and is being corrected with tv 2026-10 and tv 2026-11.This issue can cause a vacuum leak and when the harvested fat is washed in the chamber, it can cause liquids to leak from near the sliding door.The reported issue is confirmed.The cause is most likely due to the poor retention of the foam tray to the bottom of the chamber assembly.Tiger aesthetics medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: LIPOASPIRATE WASH SYSTEM
• Common Device Name: FAT TRANSFER
• Manufacturer (Section D): TIGER AESTHETICS MEDICAL; 9900-a s. 57th street; franklin WI 53132
• Manufacturer (Section G): TIGER AESTHETICS MEDICAL; 9900-a s. 57th street; franklin WI 53132
• Manufacturer Contact: joe lucas
• MDR Report Key: 24829945
• Report Number: 1651189-2026-10477
• Device Sequence Number: 18438452
• Product Code: QKL
• UDI-Device Identifier: 00810076894621
• UDI-Public: 00810076894621
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: BK190433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VIALITY-1400
• Device Catalogue Number: VIALITY-1400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown