MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-08-03 for VASERLIPO SYSTEM 110-0037 manufactured by Solta Medical Inc.
[115975023]
A local engineer checked the system and it was not passing 10% on c mode. It was determined the ultrasound board was defective. The device has been requested for further evaluation and repair, but not received. It is likely that patient may need additional therapy. A review of the lot manufacturing records is in progress.
Patient Sequence No: 1, Text Type: N, H10
[115975024]
It was reported to the distributor that a doctor has been using the machine successfully for several years. They were performing a procedure with local anesthesia on the lower abdomen of the patient. During the treatment the system stopped working, the ultrasound noise stopped, there was an alarm sound and the tissue was resistant to probing during the operation. This resulted in uneven liposuction, increased pain, bleeding and the skin did not tighten. The procedure had to be completed using direct suction by the ventx system. The consumer is currently experiencing swelling of the abdomen, and there is the potential for scarring. The consumer was treated with pain killers. Pictures were requested, however the patient refused to comply.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00075 |
| MDR Report Key | 7748629 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-08-03 |
| Date of Report | 2018-07-09 |
| Date of Event | 2018-07-09 |
| Device Manufacturer Date | 2017-10-09 |
| Date Added to Maude | 2018-08-03 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JULI MOORE |
| Manufacturer Street | 3365 TREECOURT 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 | 2018-08-03 |
| Model 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 PARKWAY N SUITE 100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-03 |