MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-08-25 for LIPOSONIX SYSTEM MODEL 2 P006373 manufactured by Solta Medical Inc..
[83726067]
The replaceable treatment cartridge was returned for evaluation. The cartridge appeared soft and some water was added to be tested at the transducer scaling factor station. The cartridge passed the transducer scaling factor and all 5 functional tests. No other problems were observed. The unit was inspected on site by our field service engineer and no damage was found.
Patient Sequence No: 1, Text Type: N, H10
[83726068]
A report received from a user facility stated that the patient underwent a liposonix treatment and presented scratches on the abdomen. There was no additional treatment required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2017-00050 |
| MDR Report Key | 6822665 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-08-25 |
| Date of Report | 2017-07-28 |
| Date of Event | 2017-07-28 |
| Date Mfgr Received | 2017-07-28 |
| Date Added to Maude | 2017-08-25 |
| 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 COURT INDUSTRIAL BLV |
| Manufacturer City | ST.LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | SOLTA MEDICAL INC |
| Manufacturer Street | 11818 NORTH CREEK PARKWAY NORTH |
| 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 CELLULAR DIS |
| Product Code | OHV |
| Date Received | 2017-08-25 |
| Returned To Mfg | 2017-08-08 |
| Model Number | P006373 |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLTA MEDICAL INC. |
| Manufacturer Address | BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-25 |