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 2017-10-26 for LIPOSONIX SYSTEM P005875 manufactured by Solta Medical.
[90416266]
Patient Sequence No: 1, Text Type: N, H10
[90416267]
The report indicated that a patient suffered skin blisters on the flanks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2017-00060 |
| MDR Report Key | 6981365 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-26 |
| Date of Report | 2017-09-27 |
| Date of Event | 2017-07-03 |
| Date Mfgr Received | 2017-09-27 |
| Date Added to Maude | 2017-10-26 |
| 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. JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST. 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 | LIPOSONIX SYSTEM |
| Generic Name | FOCUSED ULTRASOUND |
| Product Code | OHV |
| Date Received | 2017-10-26 |
| Model Number | P005875 |
| ID Number | NI |
| 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 |
| Manufacturer Address | 11720 NORTH CREEK PKWY N SUITE BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-26 |