MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-11-01 for SCULPSURE 105-7026-000 manufactured by Cynosure Inc..
[125902051]
Patient had a sculpsure laser procedure on the abdomen in (b)(6) 2016, however complained of a recent surgical removal of nodules/fat necrosis on (b)(6) 2018. Cynosure became aware of this event on october 2, 2018. When the patient was first treated with the laser, edema/erythema was experienced which are expected side effects from laser treatments. There was no medication associated with the event. The treatment parameters used in the laser procedure were followed per the clinical reference guide. There was no additional information made available by the customer site because the patient has been unresponsive. A recent device evaluation found the unit operating as intended working within specification. Though the patient's experience are expected side effects from a sculpsure laser treatment, this event is reportable because the patient sought medical intervention via a surgical procedure.
Patient Sequence No: 1, Text Type: N, H10
[125902052]
Patient had medical intervention following a laser procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2018-00024 |
| MDR Report Key | 8031043 |
| Report Source | CONSUMER |
| Date Received | 2018-11-01 |
| Date of Report | 2018-11-01 |
| Date of Event | 2016-09-27 |
| Date Mfgr Received | 2018-10-02 |
| Device Manufacturer Date | 2016-05-10 |
| Date Added to Maude | 2018-11-01 |
| 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 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 | 2018-11-01 |
| Catalog Number | 105-7026-000 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-11-01 |