VELASHAPE III
Received May 25, 2018 · Event occurred Apr 18, 2018
Report 3003772750-2018-00001 · MDR key 7544455
Device
Generic name
Velashape Iii
Manufacturer
Syneron Medical Ltd.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Additional Manufacturer Narrative
UNDER INVESTIGATION.
Description of Event or Problem
FEMALE PATIENT (B)(6) YEARS OLD WITH SKIN TYPE 3 UNDERWENT ULTRASHAPE POWER AND VELASHAPE COMBINED TREATMENT ON (B)(6) 2018 ON THE INNER THIGH AREA. ACCORDING TO THE PATIENT, THE VELASHAPE TREATMENT WAS PERFORMED FOR 10 MIN AT 43 DEGREES FOLLOW BY A TREATMENT WITH ULTRASHAPE POWER. NO BURNING WAS OBSERVED AFTER THE VELASHAPE TREATMENT. DURING THE ULTRASHAPE TREATMENT THE CUSTOMER INDICATED THAT THE PATIENT FELT A LITTLE MORE HEAT, BUT DID NOT COMPLAIN OF BURNING. WHEN THE TREATMENT WAS OVER, THE SKIN WAS A LITTLE RED BUR NOT BROKEN. ON (B)(6) 2018, PATIENT COMPLAINED ABOUT BURN ON THE INNER THIGH AREA. THE COMPANY MADE MULTIPLE ATTEMPTS TO REACH PATIENT, HOWEVER WE WERE NOT ABLE TO GET ANY ADDITIONAL INFORMATION.