VelaShape III system FG71201Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290109952031), received between May 25, 2018 and May 25, 2018 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7544455 ↗