MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-12-20 for VASERLIPO SYSTEM 110-0036 manufactured by Solta Medical, Inc..
[130986917]
The complaint product was not returned for evaluation and the serial number is unknown. 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
[130986918]
A distributor reported a patient experienced a burn. No further information was provided. Additional event and product information have been requested but have not been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00137 |
| MDR Report Key | 8184069 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-06 |
| Date of Event | 2018-07-02 |
| Device Manufacturer Date | 2016-11-01 |
| Date Added to Maude | 2018-12-20 |
| 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 | 2018-12-20 |
| Model Number | 110-0036 |
| Catalog Number | 110-0036 |
| 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; 2. Required No Informationntervention | 2018-12-20 |