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..
[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
| Report Number | 3011423170-2019-00054 |
| MDR Report Key | 8560351 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-01 |
| Date of Event | 2018-02-22 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2005-01-14 |
| Device Manufacturer Date | 2005-12-22 |
| Date Added to Maude | 2019-04-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JENNIFER GAMET |
| Manufacturer Street | 1400 NORTH GOODMAN ST |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853386853 |
| Manufacturer G1 | SOLTA MEDICAL |
| Manufacturer Street | 11720 N CREEK PARKWAY N STE 100 |
| Manufacturer City | BOTHELL WA 98011 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98011 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VASERLIPO SYSTEM |
| Generic Name | SYSTEM, SUCTION, LIPOPLASTY |
| Product Code | MUU |
| Date Received | 2019-04-29 |
| Model Number | 110-0032 |
| Catalog Number | 110-0032 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLTA MEDICAL INC. |
| Manufacturer Address | 11720 NORTH CREEK PARKWAY N SUITE 100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-29 |