MAUDE Adverse Event Report: AESTHETICS BIOMEDICAL, INC. ULTRAVISION

Catalog Number	ABMVIVS02
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Scar Tissue (2060)
Type of Reportable Event	Serious Injury
Event or Problem Description
A practice contacted aesthetics biomedical (abm) with an image of a patient with hypertrophic scarring and healing lesions on their abdomen after a recent ultravision treatment.Abm's chief medical officer (cmo) immediately initiated contact with the practice to speak with the practitioner to gain more knowledge and understanding about the treatment.The cmo spoke with the practice owner who provided information that was contained in the patient chart.The settings that were provided to the cmo included power levcel 8 (40 watts), 700 ms, 1 mhz, 2 passes at a depth of 3.9 mm with a 60-array insulated needle set.The treatment parameters were not within abm's suggested treatment guidelines for the target tissue.The cmo attempted to obtain more information, requesting that she be able to speak with the aesthetician who performed the treatment but was not given the opportunity.
Additional Manufacturer Narrative
The treatment results depicted in he image provided by the practice were not consistent with the settings reported by the owner, suggesting a more superficial depth.The treatment results reflected the amount of energy delivered was inappropriately higher than those recommended by the manufacturer for the target tissue.A certified letter was sent to the practice requiring additional training for continued use of the device.

• Brand Name: ULTRAVISION
• Common Device Name: ULTRAVISION
• Manufacturer (Section D): AESTHETICS BIOMEDICAL, INC.; 7227 n 16th st; suite 160; phoenix AZ 85020
• Manufacturer Contact: robert march ; 7227 n 16th st; suite 160; phoenix, AZ 85020
• MDR Report Key: 25073326
• Report Number: 3012204368-2026-00001
• Device Sequence Number: 13366563
• Product Code: GEI
• UDI-Device Identifier: G055ABMVIVS020
• UDI-Public: +G055ABMVIVS020/$23008/16D20230518
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K221574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2026

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: Other
• Device Catalogue Number: ABMVIVS02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TOPICAL ANESTHETIC.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female