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 2019-03-28 for VASERLIPO SYSTEM 110-0032 manufactured by Solta Medical, Inc..
[140134983]
Device not returned for evaluation. The cannula and/or probe is a piece of metal used during the patient procedure. This piece of metal does not store any treatment data and thus there is no information to gather from its return. These items are not a viable source of evaluation data and the system has no system/data logs that can be reviewed. A review of the device history records is in progress. Regarding the patient? S condition, physician did not report the device to be suspect. Based on all information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[140134984]
Physician reported performing procedure on (b)(6) 2019 on a female patient. Treated areas included upper and lower abs, flanks, lateral and medial thighs, and lower legs. It was reported that the patient had no complications prior, during, or directly post procedure. On (b)(6) 2019, patient presented with signs of acute anemia. Patient was admitted to the hospital and underwent a blood transfusion. It was reported that the patient was released from the hospital in good condition. Physician reported that the patient has a history of recurrent vasovagal and orthostatic hypotension and was therefore referred to endocrinology for evaluation. It was noted that the aspirate during the (b)(6) 2019 procedure was not bloody and that the patient did not develop any hematomas after the procedure. Additionally, no system errors occurred with respect to the device and the physician did not notice anything out of the ordinary during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2019-00044 |
| MDR Report Key | 8458954 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-28 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-02-23 |
| Device Manufacturer Date | 2018-12-07 |
| Date Added to Maude | 2019-03-28 |
| 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 | MRS. JENNIFER GAMET |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853386853 |
| 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 | 2019-03-28 |
| Model Number | 110-0032 |
| Catalog Number | 110-0032 |
| 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 | 11720 NORTH CREEK PKWY N SUITE 100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-03-28 |