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 VELASHAPE III manufactured by Syneron Medical Ltd..
[109253310]
Under investigation.
Patient Sequence No: 1, Text Type: N, H10
[109253311]
Female patient (b)(6) years old with skin type 3 underwent ultrashape power and velashape combined treatment on (b)(6) 2018 on the inner thigh area. According to the patient, the velashape treatment was performed for 10 min at 43 degrees follow by a treatment with ultrashape power. No burning was observed after the velashape treatment. During the ultrashape treatment the customer indicated that the patient felt a little more heat, but did not complain of burning. When the treatment was over, the skin was a little red bur not broken. On (b)(6) 2018, patient complained about burn on the inner thigh area. The company made multiple attempts to reach patient, however we were not able to get any additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003772750-2018-00001 |
| MDR Report Key | 7544455 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-25 |
| Date of Report | 2018-05-24 |
| Date of Event | 2018-04-18 |
| Date Mfgr Received | 2018-04-27 |
| 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 | YVERRE BOBAY |
| Manufacturer Street | 530 BOSTON POST ROAD |
| Manufacturer City | WAYLAND MA 01778 |
| Manufacturer Country | US |
| Manufacturer Postal | 01778 |
| Manufacturer G1 | SYNERON-CANDELA CORP. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VELASHAPE III |
| Generic Name | VELASHAPE III |
| Product Code | NUV |
| Date Received | 2018-05-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERON MEDICAL LTD. |
| Manufacturer Address | SYNERON MEDICAL LTD INDUSTRIAL ZONE, PO BOX 550 YOKNEAM ILLIT, IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-25 |