VASERLIPO SYSTEM
Received May 3, 2023
Report 3011423170-2023-00046 · MDR key 16859822
Device
Generic name
System, Suction, Lipoplasty For Removal
Manufacturer
Solta Medical, IncModel number
UNKNOWNProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Burn(s)
- Necrosis
- Burn(s)
- Necrosis
Narrative
Additional Manufacturer Narrative
ATTEMPTS ARE BEING MADE TO LOCATE THE SURGEON AND THE DEVICE. THE INVESTIGATION IS UNDERWAY.
Description of Event or Problem
A CUSTOMER REPORTED THAT A FELLOW PLASTIC SURGEON SHOWED HIM PHOTOS OF A PATIENT THAT HAD A LIPOSCULPTURE SURGERY PERFORMED IN TURKEY WITH THE VASER EQUIPMENT. THE PLASTIC SURGEON EXPLAINED THAT THE PATIENT HAS BURNS OF THE ABDOMEN AND BACK WITH EXTENSIVE SKIN NECROSIS AND THAT THE PATIENT IS IN THE INTENSIVE CARE UNIT WITH SKIN GRAFTS FOR BURNS. NO OTHER INFORMATION WAS PROVIDED. ATTEMPTS ARE BEING MADE TO LOCATE THE PLASTIC SURGEON. THE FILE WILL BE UPDATED AS MORE INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
NO PRODUCT WAS RETURNED FOR EVALUATION OR ANY FURTHER INFORMATION ABLE TO BE OBTAINED. PATIENT BURNS ARE A KNOWN POSSIBLE SIDE EFFECT OF VASER TREATMENT ACCORDING TO THE VASERLIPO SYSTEM RISK ASSESSMENT. THE TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. BASED ON THE AVAILABLE INFORMATION IN THE CASE, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSIONS CAN BE DRAWN. NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME.
Description of Event or Problem
EXTENSIVE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO LOCATE THE DEVICE AND HEALTHCARE PROFESSIONAL REGARDING THIS EVENT. THE DOCTOR THAT REPORTED THIS EVENT TO SOLTA MEDICAL HAS NO OTHER INFORMATION TO PROVIDE.