MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-08 for VASERLIPO SYSTEM 110-0032 manufactured by Solta Medical, Inc..
[135534201]
Additional information has been requested but has not been received. The complaint device was not returned for evaluation. A review of the device history records is in progress. The complaint investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[135534202]
Physician performed procedure on (b)(6) 2018 wherein (b)(6)-year-old female patient underwent liposuction of the abdomen, lateral chest wall and back. Physician reports that post-surgery the patient is having? Significant pain? And is? Unhappy with the increase in loose skin that she has currently?. Additional information has been requested but has not been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2019-00009 |
| MDR Report Key | 8320745 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-08 |
| Date of Report | 2019-01-29 |
| Date of Event | 2018-12-04 |
| Device Manufacturer Date | 2015-11-25 |
| Date Added to Maude | 2019-02-08 |
| 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. 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, INC. |
| 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 | 2019-02-08 |
| Model 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 PKWY N SUITE 100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-08 |