MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2016-09-09 for SCULPSURE 100-7026-010 manufactured by Cynosure Inc.
[54303177]
Patient experienced a fever and abscess on thighs from laser treatment with the sculpsure. Treatment parameters were not within clinical guidelines and the sculpsure device is currently not indicated for application on the thighs. Patient was given augmentin and pyostacine as preventative care medication. The patient also had medical intervention as it was under the care of it's physician. The device was evaluated and operated as intended. This is a reportable incident because the patient had medical intervention.
Patient Sequence No: 1, Text Type: N, H10
[54303178]
Patient had medical intervention from a laser procedure on the thigh region.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2016-00043 |
| MDR Report Key | 5939165 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2016-09-09 |
| Date of Report | 2016-09-09 |
| Date of Event | 2016-07-26 |
| Date Mfgr Received | 2016-08-22 |
| Date Added to Maude | 2016-09-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CYNOSURE INC |
| Manufacturer Street | 5 CARLISLE RD. |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal | 01886 |
| Manufacturer Phone | 9783678736 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCULPSURE |
| Generic Name | SCULPSURE |
| Product Code | PKT |
| Date Received | 2016-09-09 |
| Catalog Number | 100-7026-010 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYNOSURE INC |
| Manufacturer Address | 5 CARLISLE RD WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-09 |