VASERLIPO VASER PRO AMPLIFIER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-15 for VASERLIPO VASER PRO AMPLIFIER manufactured by Solta Medical Inc..

Event Text Entries

[133102317] I am a plastic surgeon and on (b)(6) 2018 i had a case of a young lady who asked me to remove localize fat from the lateral part of the thighs and the lateral part of the abdomen. I used the vaserlipo device and the parameters that i used were the following: the wetting solution was of about 600ml for each side at the lateral thighs; at the same areas the probe of three rings; the settings were at 80%. I delivered energy for 5 mins and 43 seconds to the right side and 5 min to the left side. The energy was only delivered to the deep layer of the fat. Superficial layers were left untouched. No malfunction indication appeared on the vaser device. I did not do superficial lipolysis at all, i have followed all the guidelines that the company of the vaser suggests. After this treatment, no signs of any problem appeared and the pt has been discharged. A few days later, i saw that in the area a very severe burn was provoked. The burn was involving the whole thickness of the skin and fat as well, up to the underline muscles. It has happened to both areas of the lateral thighs and in a smaller grade at the lateral part of the abdomen. The burned area was extended to the limits and sometimes beyond the limits of the localized fat. If photos are needed, we are ready to provide them. The manufactured day of the device is july 14th 2017. After research, following the incident, we found that there has been a recall of some vaser devices [no. Of fda recall z-3047-2017 and z-3048-2017, (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5083101
MDR Report Key8248911
Date Received2019-01-15
Date of Report2019-01-14
Date of Event2018-10-30
Date Added to Maude2019-01-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVASERLIPO
Generic NameSYSTEM, SUCTION, LIPOPLASTY
Product CodeMUU
Date Received2019-01-15
Model NumberVASER PRO AMPLIFIER
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSOLTA MEDICAL INC.
Manufacturer AddressBOTHELL WA 98011 US 98011


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit 2019-01-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.