InjuryISA
ULTRASONIC CAVITATION AND RADIO FREQUENCY
Received Feb 24, 2023 · Event occurred Jan 19, 2023
Report MW5115260 · MDR key 16447570
Device
Generic name
Massager, Therapeutic, Electric
Manufacturer
UnkProduct problems
- Patient-Device Incompatibility
Patient
41 YR · Female
- Hearing Impairment
- Pain
- Burning Sensation
- Shaking/Tremors
- Neuralgia
- Hearing Impairment
- Pain
- Burning Sensation
- Shaking/Tremors
- Neuralgia
Narrative
Description of Event or Problem
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.