MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-11 for SCULPSURE manufactured by Cynosure Inc..
[120190531]
I can't remember the exact date - (b)(6) or early (b)(6), i had sculpsure done on my inner thighs in (b)(6). After 6 weeks, no result. After 12 weeks, it seemed that my fat was just lumpy and my skin more "ziggley. " the procedure was extremely painful and 6 months later, i still feel tingling. I feel i have some nerve damage or connective tissue damage but no evidence of fat loss. There is no improvement in size or skin tone. I paid over (b)(6). This procedure as well as other fat loss treatment don't seem to work and they may be detrimental. I feel duped and embarrassed. Why do you allow this? It's consumer fraud and doctors get paid no matter what. This procedure does not work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079714 |
| MDR Report Key | 7868688 |
| Date Received | 2018-09-11 |
| Date of Report | 2018-09-09 |
| Date of Event | 2018-04-19 |
| Date Added to Maude | 2018-09-12 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 0 |
| Brand Name | SCULPSURE |
| Generic Name | LASER FOR DISRUPTION OF ADIPOCYTE CELLS FOR AESTHETIC USE |
| Product Code | PKT |
| Date Received | 2018-09-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYNOSURE INC. |
| Manufacturer Address | 5 CARLISLE ROAD WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-11 |