MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-05-13 for VELASHAPE AND ULTRASHAPE FG71051US manufactured by Syneron Medical Ltd.
[5950639]
On (b)(6) 2015 syneron qa was made aware of a possible adverse event that occurred to a pt of laser md medspa. Pt reportedly sustained burns post treatment with ultrashape treatment followed by velashape ii treatment on the abdomen on the same day. Pt (b)(6) is a female caucasian pt treated on the abdomen for circumference reduction. Ultrashape procedure had the following settings: horizontal treatment was used with 8 actual focal zones. Parker ultrasound gel was used along with straps, and transducer surface appeared smooth. Velashape ii treatment parameters are unk at this time. Post treatment, pt was given aquaphor with non-stick gauzes. Pt experienced minor redness without discomfort around the belly button area during ultrashape procedure. Velashape ii procedure was performed after, avoiding the bell button area. From photos taken 1 day post treatment, the burns appear to be low in severity. The clinic stated that the burns were first degree burns. However the subsequent photos (received on 04/27/2015) show blisters moderate in severity during what should have been recovery period.
Patient Sequence No: 1, Text Type: D, B5
[13444401]
Upon reviewing all available data and information at this moment in time, the most probable root cause is unk due to lack of treatment information and equipment information. Upon arrival testing of the system involved is pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004772125-2015-00001 |
| MDR Report Key | 4774378 |
| Report Source | 05,06 |
| Date Received | 2015-05-13 |
| Date of Report | 2015-05-12 |
| Date of Event | 2015-04-07 |
| Date Mfgr Received | 2015-04-20 |
| Date Added to Maude | 2015-05-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SAM WADE |
| Manufacturer Street | PO BOX 550 INDUSTRIAL ZONE |
| Manufacturer City | YOKNEAM, ILLIT 20692 |
| Manufacturer Country | IS |
| Manufacturer Postal | 20692 |
| Manufacturer Phone | 8447515 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VELASHAPE AND ULTRASHAPE |
| Generic Name | NONE |
| Product Code | NUV |
| Date Received | 2015-05-13 |
| Model Number | FG71051US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERON MEDICAL LTD |
| Manufacturer Address | YOKNEAM ILLIT IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-13 |