MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-09-12 for SCULPSURE 105-7026-000 manufactured by Cynosure Inc..
[120006980]
In this incident, patient experienced swelling on the submental area following a laser procedure with the sculpsure. However, due to the appearance of the swollen area, the site performed an exicision of the targeted fat on the submental area. There was no additional information provided by the customer site regarding the patient/treatment details. The device was evaluated and found operating as intended within specification. Patient has now healed and is doing well. Swelling is an expected transient side effect from laser treatments, however the incident involved a surgical procedure (excision of fat), which makes this a reportable event.
Patient Sequence No: 1, Text Type: N, H10
[120006981]
Patient had a surgical procedure on the submental area following a laser treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2018-00019 |
| MDR Report Key | 7870273 |
| Report Source | CONSUMER |
| Date Received | 2018-09-12 |
| Date of Report | 2018-09-12 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-08-13 |
| Date Added to Maude | 2018-09-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 5 CARLISLE ROAD |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal | 01886 |
| 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 | 2018-09-12 |
| Catalog Number | 105-7026-000 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2018-09-12 |