MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-19 for SCULPSURE manufactured by Cynosure.
[111910503]
I had sculpsure (a cynosure procedure) performed almost a year ago and had four big problems with it: it is advertised as "painless and comfortable. " that couldn't be further from the truth. I went through the worst contractions you can imagine when i had my last daughter and it is similar to that. It is pain that is probably a 9 on a scale of 10. During the procedure, i didn't think i could carry on. The only reason i was able to is because there are brief waves of no pain in between the excruciating pain; it left me with permanent scar tissue. Balls of scar tissue under my skin on each thigh where i had the procedure performed; i wasn't told that i would need multiple procedures to see results, but after the fact when i told them about the scar tissue they recommended i do the procedure again; the sculpsure yielded no positive cosmetic results whatsoever.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077949 |
| MDR Report Key | 7619211 |
| Date Received | 2018-06-19 |
| Date of Report | 2018-06-18 |
| Date of Event | 2017-06-23 |
| Date Added to Maude | 2018-06-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 DISRUPTION OF ADIPOCYTE CELLS |
| Product Code | PKT |
| Date Received | 2018-06-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYNOSURE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-19 |