MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-13 for VASERLIPO SYSTEM 110-0021 manufactured by Solta Medical, Inc..
[130170757]
The complaint product was not returned for evaluation. A review of the device history records is in progress. Based on available information, no causal factors can be determined and no conclusions can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[130170758]
A practitioner reported that a patient underwent a liposuction treatment on (b)(6) 2018 and that almost seven weeks post procedure ((b)(6) 2018) it was noted that the patient had a thermal burn on their right lower anterior flank. The patient was prescribed an antibiotic ointment. The practitioner reported that the patient is healing but that it is unknown if there will be any permanent damage or scarring. No other treatments had been performed in the same area where the symptom was reported and the patient had not undergone any other treatments in the same symptom-area within the past 30 days. It was reported that during the treatment no system errors occurred and the practitioner did not notice anything out of the ordinary. Additional event information has been requested but has not been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00131 |
| MDR Report Key | 8159413 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-13 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-11-12 |
| Device Manufacturer Date | 2013-02-19 |
| Date Added to Maude | 2018-12-13 |
| 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 | VASERLIPO SYSTEM |
| Generic Name | SYSTEM, SUCTION, LIPOPLASTY |
| Product Code | MUU |
| Date Received | 2018-12-13 |
| Returned To Mfg | 2019-03-04 |
| Model Number | 110-0021 |
| Catalog Number | 110-0021 |
| 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 | 2018-12-13 |