MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-09-26 for SCULPSURE 100-7026-010 105-7026-000 manufactured by Cynosure Inc..
[121851632]
In this incident, patient experienced swelling and pain following a laser procedure with the sculpsure. The patient was given medication for post treatment care and had medical intervention at the emergency room. User error was involved in the event because the treatment parameters were not followed per the clinical reference guide. The device was evaluated and operated as intended within specification. Permanent injury is not expected from this event. Patient is now doing better, healing well from the event. Swelling and pain are expected side effects from laser treatments, however this is reportable because the patient had medical intervention.
Patient Sequence No: 1, Text Type: N, H10
[121851633]
Patient had medical intervention following a laser procedure for swelling/pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2018-00022 |
| MDR Report Key | 7911697 |
| Report Source | CONSUMER |
| Date Received | 2018-09-26 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-08-27 |
| Date Mfgr Received | 2018-09-04 |
| Device Manufacturer Date | 2017-03-15 |
| Date Added to Maude | 2018-09-26 |
| 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 | 2018-09-26 |
| Model Number | 100-7026-010 |
| 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 | 2018-09-26 |