MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-02-20 for VASERLIPO SYSTEM 110-0037 manufactured by Solta Medical Inc..
[136627965]
Product has not been returned. Additional event information has been requested, but not received. A review of the lot manufacturing records is in progress.
Patient Sequence No: 1, Text Type: N, H10
[136627966]
Medwatch report received from fda, mw5083101. Through the medwatch program it was reported that on (b)(6) 2018, a plastic surgeon removed localized fat from the lateral part of the thighs and abdomen on a patient. During the procedure, 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%. Energy was delivered for 5 minutes and 43 seconds to the right side and 5 minutes 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 device during the procedure. Patient was discharged with no issues. A few days later, the patient returned with a very severe burn which involved the whole thickness of the skin and fat, up to the underlining muscles on both thighs and a smaller grade at the lateral part of the abdomen. The burn area was extended to the limits and sometimes beyond the limits of the localized fat. Additional event information and pictures have been requested, but not received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2019-00018 |
| MDR Report Key | 8353541 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-02-20 |
| Date of Report | 2019-01-23 |
| Date of Event | 2018-10-30 |
| Device Manufacturer Date | 2017-07-14 |
| Date Added to Maude | 2019-02-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JULI MOORE |
| Manufacturer Street | 3365 TREE CT INDUSTRIAL BLVD |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VASERLIPO SYSTEM |
| Generic Name | SYSTEM, SUCTION, LIPOPLASTY |
| Product Code | MUU |
| Date Received | 2019-02-20 |
| Model Number | 110-0037 |
| Catalog Number | 110-0037 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLTA MEDICAL INC. |
| Manufacturer Address | 11720 NORTH CREEK PKWY SUITE 100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-20 |