InjuryPKT
BODYSCULP
Received Feb 18, 2025 · Event occurred Dec 20, 2024
Report 3031944951-2025-00001 · MDR key 21396365
Device
Generic name
Low Level Laser For Aesthetic Use
Manufacturer
Rohrer Aesthetics, Inc.Model number
BODYSCULPProduct problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
47 YR · Female
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
ROHRER AESTHETICS WAS INFORMED OF THE ADVERSE EVENT THROUGH THE FDA MEDWATCH VOLUNTARY SYSTEM REPORT NUMBER MW51641178. PATIENT CLAIMS THAT THE BODYSCULP CAUSED "SERIOUS BURNS FROM THE INSIDE OUT".
Additional Manufacturer Narrative
BECAUSE ORIGINAL REPORTER DID NOT GIVE ADDRESS, CLINIC OR USER FACILITY INFORMATION, WE WERE UNABLE TO INVESTIGATE HER SPECIFIC CONCERN. WE INVESTIGATED OUR CURRENT COMPLAINT FILES TO SEE IF WE COULD MATCH THIS CASE UP TO ONE ON FILE AND HAD NO FINDINGS.