VASERLIPO SYSTEM 110-0032

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2019-04-29 for VASERLIPO SYSTEM 110-0032 manufactured by Solta Medical Inc..

Event Text Entries

[143402203] The doctor confirmed that the unit was tested prior to the procedure and it passed all tests. No system errors or anything out of the ordinary occurred during the procedure. The doctor declined to return the product for evaluation. System has no system/data logs that can be reviewed. A review of the device history records is in progress.
Patient Sequence No: 1, Text Type: N, H10


[143402204] It was reported by a patient's lawyer that the consumer underwent correction of bilateral gynecomastia with suction-assisted lipectomy, vaser-assisted ultrasound, and direct excision of breast tissue on (b)(6) 2018. The procedure resulted in subcutaneous thermal burns which "maimed and disfigured" the patient. Follow-up information obtained from the treating doctor confirmed the patient was treated on their anterior and lateral chest (bilateral). The time of the procedure with the complaint device was 6 minutes on each side. The physician was able to complete the procedure and the highest amplitude level used was 90%. The patient returned to the office 2-3 weeks later with bilateral seromas on both sides of the anterior chest and nipple-areola complex. This was treated with serial aspiration. A few weeks later the patient developed scar contractures after normal fat induction and skin contour irregularities failed to resolve and actually worsened. This was treated with multiple sessions of lymphatic drainage and scar massage. The doctor was unable to comment if the patient has any permanent scarring or damage as they have not evaluated the patient in the past 5-6 months. As far as the doctor knows, the patient has resumed their daily routine and physical activity.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011423170-2019-00054
MDR Report Key8560351
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2019-04-29
Date of Report2019-04-01
Date of Event2018-02-22
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2005-01-14
Device Manufacturer Date2005-12-22
Date Added to Maude2019-04-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. JENNIFER GAMET
Manufacturer Street1400 NORTH GOODMAN ST
Manufacturer CityROCHESTER NY 14609
Manufacturer CountryUS
Manufacturer Postal14609
Manufacturer Phone5853386853
Manufacturer G1SOLTA MEDICAL
Manufacturer Street11720 N CREEK PARKWAY N STE 100
Manufacturer CityBOTHELL WA 98011
Manufacturer CountryUS
Manufacturer Postal Code98011
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameVASERLIPO SYSTEM
Generic NameSYSTEM, SUCTION, LIPOPLASTY
Product CodeMUU
Date Received2019-04-29
Model Number110-0032
Catalog Number110-0032
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Sequence No1
Device Event Key0
ManufacturerSOLTA MEDICAL INC.
Manufacturer Address11720 NORTH CREEK PARKWAY N SUITE 100 BOTHELL WA 98011 US 98011


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-04-29

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