MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-25 for ULTRASHAPE POWER FG71481US manufactured by Syneron Medical Ltd. Yokneam, Illit, Israel.
[109270116]
An evaluation of the ultrashape power system was performed at the customer site by a syneron-candela field technician on 5-2-2018, including functional testing of the four transducers at the site. All systems met functional specifications and no discrepancies were identified. In addition, syneron-candela service technicians evaluated the returned velashape iii system on 5-2-2018 and the two applicators used in the procedure on (b)(6) 2018. The evaluation revealed no observed system issues and the applicators were all within specification. Although a definitive root cause could not be determined in this case, causes that may lead to burns and blisters include: dirty/contaminated transducers. Treatment of fat thickness less than specified in the user manual. Insufficient ultrasound gel on treatment area. Not using a level treatment plane. Skin surface factors such as hair, body jewelry, bubbles in ultrasound gel, presence of other skin products on treatment area. The root cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[109270117]
Female patient, (b)(6) with skin type iii, underwent combined treatment on (b)(6) 2018 and reported burn on inner thigh area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003772750-2018-00002 |
| MDR Report Key | 7544800 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-25 |
| Date of Report | 2018-05-25 |
| Date of Event | 2018-04-18 |
| Date Mfgr Received | 2018-04-27 |
| Device Manufacturer Date | 2017-07-30 |
| Date Added to Maude | 2018-05-25 |
| 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 | SHARON TIMBERLAKE |
| Manufacturer Street | 530 BOSTON POST ROAD |
| Manufacturer City | WAYLAND MA 01778 |
| Manufacturer Country | US |
| Manufacturer Postal | 01778 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASHAPE POWER |
| Generic Name | ULTRASOUND BODY CONTOURING DEVICE |
| Product Code | OHV |
| Date Received | 2018-05-25 |
| Model Number | FG71481US |
| Catalog Number | FG71481US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERON MEDICAL LTD. YOKNEAM, ILLIT, ISRAEL |
| Manufacturer Address | SYNERON MEDICAL LTD. YOKNEAM ILLIT, IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-25 |