MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-03 for CYNOSURE SCULPSURE manufactured by Cynosure, Inc. / Hologic, Inc..
[122489359]
Pt underwent sculpsure (noninvasive laser lipolysis) for body contouring. Developed severe pain, blistering with second and third degree burns of the abdomen. Required debridement, months of wound care and now has permanent scarring and a deformed abdomen. Procedure performed by an ophthalmology office with no training in body contour procedures. The procedure and the f/u care was not provide at my office.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080296 |
| MDR Report Key | 7929854 |
| Date Received | 2018-10-03 |
| Date of Report | 2018-10-01 |
| Date of Event | 2018-04-17 |
| Date Added to Maude | 2018-10-03 |
| 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 | CYNOSURE SCULPSURE |
| Generic Name | LASER FOR DISRUPTION OF ADIPOSE CELLS FOR AESTHETIC USE |
| Product Code | PKT |
| Date Received | 2018-10-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYNOSURE, INC. / HOLOGIC, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-10-03 |