MAUDE Adverse Event Report: Solta Medical, Inc. VaserLipo System; System, Suction, Lipoplasty

Model Number	110-0037
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Ecchymosis (1818); Erythema (1840); Pain (1994); Rash (2033); Burning Sensation (2146); Blister (4537)
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported pain and a burn to the patient's abdomen during a vaser procedure.The initial patient report notes that the individual experienced severe pain, a burning sensation, and a subsequent skin reaction described textually as a rash following the use of the medical device.Available images were reviewed by the medical reviewer.Visual inspection of the first image reveals a significant localized adverse skin reaction on the right abdominal and flank area.The affected region exhibits a sharply demarcated, erythematous, and edematous plaque covered with multiple tense, fluid-filled bullae of varying sizes.The underlying skin demonstrates a distinctive, regular textured grid pattern, suggesting direct contact or thermal/mechanical energy transfer from the device.In the second image, which appears to capture the same anatomical region at a different point in clinical management or healing, the large bullae seen previously are largely deflated or ruptured, leaving behind smaller residual fluid-filled vesicles.This image more prominently highlights the extensive, well-defined grid-like patterning across the hyperemic skin, along with substantial deep bruising and ecchymosis extending across the lateral flank eight days after receipt of this report, the physician states that all wounds have been treated, and the condition of the patient is currently stable.More information has been requested.
Additional Manufacturer Narrative
More information has been requested.The case is underway.

• Brand Name: VaserLipo System
• Common Device Name: System, Suction, Lipoplasty
• Manufacturer (Section D): Solta Medical, Inc.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): Solta Medical, Inc.; 11720 north creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 north creek pkwy n; suite 100; bothell, WA 98011
• MDR Report Key: 50060777
• Report Number: 3011423170-2026-00334
• Device Sequence Number: 13041363
• Product Code: QPB
• UDI-Device Identifier: 00850608002537
• UDI-Public: 00850608002537
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K190551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 110-0037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown