MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for SCULPSURE manufactured by Cynosure Llc.
[144477897]
Painful subcutaneous nodule in abdominal fat after sculpsure treatment (a cynosure device). She had two treatments with the device which were described by personnel from cynosure as being almost pain-free. She was told that there were rare tender nodules that resolve in a couple of months. It has been a year and she still complains of a tender nodule, which is easily palpable in her right abdomen. There is a culture of misrepresentation of safety issues with cynosure personnel. The sales force of cynosure consistently misrepresent aspects of the sculpsure device including misrepresenting financial details that affect treatment decisions, efficacy with regard to variable outcomes, and safety issues with regard to pain and subcutaneous nodules. The sculpsure device is a laser-mediated fat destruction device used primarily for cosmetic reasons. I have a picture of the product. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086445 |
| MDR Report Key | 8591075 |
| Date Received | 2019-05-07 |
| Date of Report | 2019-05-04 |
| Date of Event | 2018-05-01 |
| Date Added to Maude | 2019-05-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCULPSURE |
| Generic Name | LASER FOR DISRUPTION OF ADIPOCYTE CELLS FOR AESTHETIC USE |
| Product Code | PKT |
| Date Received | 2019-05-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYNOSURE LLC |
| Manufacturer Address | MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-07 |