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 2017-06-22 for LIPOSONIX SYSTEM MODEL 2 P005999 manufactured by Solta Medical Inc..
[78227163]
A field service engineer was dispatched to the facility to inspect the device. The system was tested and was found to be fully functional. The customer was informed of the evaluation results and was satisfied the system is functioning normally. Retrieve the treatment data and to evaluate the unit. The visual examination did not find any damage. Additional information received from the clinician states the patient had a bmi of 20 which is below the recommended bmi of 23. Clinician was advised to follow the minimum bmi of 23.
Patient Sequence No: 1, Text Type: N, H10
[78227164]
A report from a user facility stated the patient underwent a liposonix treatment on the left and right flank. After the treatment, the patient developed a watery blister with a reddish inflamed square on each flank, close to the rear of the ribcage. The square appeared similar in size to the transducer head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2017-00032 |
| MDR Report Key | 6661797 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-06-22 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-05-23 |
| Date Mfgr Received | 2017-05-25 |
| Date Added to Maude | 2017-06-22 |
| 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 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 DES |
| Product Code | OHV |
| Date Received | 2017-06-22 |
| Model Number | P005999 |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2017-06-22 |