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 2019-01-08 for VASERLIPO SYSTEM 110-0032 manufactured by Solta Medical, Inc..
[132489921]
A field service engineer performed a functional test on site and the system passed the test per the service manual. The system is in the process of being returned for further investigation. A review of the device history records is in progress. Based on all available information, no causal factors can be determined and no conclusions can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[132489922]
A physician reported a possible perfusion complication post abdominal liposuction. It was also reported the system was over powering. A photo of the patient was reviewed. The photo indicates a burn. Bruising and erythema is also visible on the lower abdomen. It is unclear when the injury occurred post procedure and whether the patient had other procedures before and after this procedure. Additional information was requested but has not been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2019-00001 |
| MDR Report Key | 8228437 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-08 |
| Date of Report | 2018-12-09 |
| Date of Event | 2018-12-09 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-07-10 |
| Device Manufacturer Date | 2014-01-09 |
| Date Added to Maude | 2019-01-08 |
| 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 | 2019-01-08 |
| Model Number | 110-0032 |
| Catalog Number | 110-0032 |
| 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 | 2019-01-08 |