MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-09-14 for VELASHAPE FG00121 manufactured by Syneron Medical Ltd..
[2891473]
Syneron was made aware on (b)(6) 2012, of an injury sustained by a female pt who received treatment with a syneron product on (b)(6) 2012. The complaint arrived in a form of a letter from the pt's lawyer addressed to the medical director of the clinic where the pt was treated. The treatment and injury was described in this letter. Pt was treated with the velashape system on the arm area by tech. The tech started the treatment on the lowest setting, and maneuvered the device's vacuum in a vertical motion, massaging the pt's right arm. Initially, the tech would check the skin after each stroke. The tech increased the intensity of the treatment, and began using her phone, and left the machine stationary on the one part of the pt's right arm. The pt complained about discomfort. After decreasing the device setting, the tech notified the pt that a blister was forming on her arm from the treatment. The pt sought care from her primary physician and urgent care, and was prescribed silvadene, steroid injection, and antibiotic. During follow up with the emergency physician on (b)(6) 2012, the doctor noticed that the burn was not healing and consulted with a plastic surgeon who diagnosed the pt with a 3rd degree burn and recommended skin graft to help heal the wound and lessen the appearance of a scar.
Patient Sequence No: 1, Text Type: D, B5
[10182206]
It is syneron procedure to request a system that was used in a procedure that ended with an injury to be examined. The clinic (syneron customer) refused and stated that the system is working properly to their satisfaction. The clinic did not answer syneron request for more info on the event, system setting, pt previous treatments, operator training records, etc. Due to lack of cooperation from the clinic and based on pt complaint, only the most probable root cause of this injury is a user error not following syneron clinical guide.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004772125-2012-00004 |
| MDR Report Key | 2750329 |
| Report Source | 05 |
| Date Received | 2012-09-14 |
| Date of Report | 2012-09-01 |
| Date of Event | 2012-04-06 |
| Date Mfgr Received | 2012-08-27 |
| Date Added to Maude | 2012-09-20 |
| 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 | 0 |
| Manufacturer Street | P.O.B 550 INDUSTRIAL ZONE |
| Manufacturer City | YOKNEAM ILLIT 20692 |
| Manufacturer Country | IS |
| Manufacturer Postal | 20692 |
| Manufacturer Phone | 543303402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VELASHAPE |
| Generic Name | MASSAGER, VACUUM |
| Product Code | NUV |
| Date Received | 2012-09-14 |
| Model Number | FG00121 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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; 2. Deathisabilit | 2012-09-14 |