MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-18 for LIPOSONIX SYSTEM MODEL 2 P006373 manufactured by Solta Medical, Inc..
[111380625]
The replaceable treatment cartridge (rtc) was returned and found to be deflated. The rtc was filled with fluid for testing. Rtc passed all testing performed. System event logs from the patient? S treatment date were also provided. Logs show that 70 sites were treated at 60j fluence level using the rtc. Logs also show that during the treatment, three decoupling warnings occurred as well as two? Cap low? Warnings. These events pause treatment but do not require a system reset to continue treatment. Therefore, display of these system messages during treatment is unrelated to the event. System was operating within all normal parameters. A review of the device history records is in progress.
Patient Sequence No: 1, Text Type: N, H10
[111380626]
A report received from taiwan stated that a patient who received liposonix treatment on (b)(6) 2018 reported to her treating physician on (b)(6) 2018 that she experienced burns, scabbing, and scratches on the back of her legs and buttocks post-procedure. No other treatments were being performed in the same area where the symptoms were reported and the patient had not undergone any other treatments in the same symptom-area within the past 30 days. Twenty minutes prior to the procedure on (b)(6) 2018 the patient took one arcoxia tablet prophylactically for pain relief. During the procedure, the physician made use of an iv with injected pethidine 50mg/1ml and dormicum 5mg/5ml for the patient. Physician reported that the patient indexed (scored) her pain during treatment at five to six. After the procedure, skin swelling and redness was noted. The patient was provided with a steroid ointment. Patient did not apply any heat, ice, or over-the-counter medications post-procedure. Burn classified in the 1st degree (superficial redness and swelling - specifically: surface swelling) and 2nd degree (blister, minor? Specifically: slight blisters appeared). Physician reported that the patient returned to the clinic on (b)(6) 2018 to undergo another liposonix treatment, this time for her inner thigh, lateral thigh, and inner knee. This treatment was completed without incident or abnormality. No adverse event experienced. It is reported that the patient is not currently experiencing any discomfort. The physician reported that they are waiting for the scabbing to fall off to treat the patient for the remaining pigmentation with nd-yag laser. Finally, physician reported that this patient has been successfully undergoing liposonix treatments for four years and that this is the first time they have experienced an event such as this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00059 |
| MDR Report Key | 7610696 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-18 |
| Date of Report | 2018-05-19 |
| Date of Event | 2018-05-18 |
| Date Mfgr Received | 2018-05-19 |
| Device Manufacturer Date | 2016-06-09 |
| Date Added to Maude | 2018-06-18 |
| 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. JULI MOORE |
| Manufacturer Street | 3365 TREE CT. INDUSTRIAL BLVD. |
| Manufacturer City | SAINT 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 | LIPOSONIX SYSTEM MODEL 2 |
| Generic Name | FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL |
| Product Code | OHV |
| Date Received | 2018-06-18 |
| Returned To Mfg | 2018-06-11 |
| Model Number | P006373 |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLTA MEDICAL, INC. |
| Manufacturer Address | 11720 NORTH CREEK PKWY N SUITE 100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-18 |