MAUDE Adverse Event Report: ULTRASONIC CAVITATION AND RADIO FREQUENCY; MASSAGER, THERAPEUTIC, ELECTRIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hearing Impairment (1881); Pain (1994); Burning Sensation (2146); Shaking/Tremors (2515); Neuralgia (4413)

Event Date 01/19/2023

Event Type  Injury  

Event Description

Fda approved ultrasonic cavitation and radio frequency treatment at sculpt lift in (b)(6).Lost hearing same day, severe shaking after treatment and developed burning pain that turned out to be a spinal lesion known as myelitis.Hospitalized for 5 days at (b)(6).Not sure of long term health effects but left with nerve damage, nerve burning, radiating nerve pain in legs, bone pains.

• Brand Name: ULTRASONIC CAVITATION AND RADIO FREQUENCY
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• MDR Report Key: 16447570
• MDR Text Key: 310380310
• Report Number: MW5115260
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/21/2023

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?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Hospitalization; Life Threatening
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White