MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-07-06 for SCULPSURE 105-7026-000 manufactured by Cynosure Inc..
[113306868]
Patient developed nodules on the thigh region, but indicated feeling fine/no issues following the laser procedure. Nodules are expected side effects that can appear from a sculpsure laser procedures. There was no medication associated with this incident. Treatment parameters and technique were followed per the device's clinical reference guide. The patient had a surgical procedure performed for an unrelated issue and ended up having the nodules removed as well. The device was evaluated and operated as intended within specification. Though, the origin of the surgical removal was not a direct result of the laser procedure, this event is now considered as medical intervention because the nodules were associated with the patient's surgery.
Patient Sequence No: 1, Text Type: N, H10
[113306869]
Patient had nodules surgically removed from the thighs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2018-00012 |
| MDR Report Key | 7666172 |
| Report Source | CONSUMER |
| Date Received | 2018-07-06 |
| Date of Report | 2018-07-06 |
| Date of Event | 2017-01-20 |
| Date Mfgr Received | 2018-06-08 |
| Device Manufacturer Date | 2016-05-16 |
| Date Added to Maude | 2018-07-06 |
| 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 | 2018-07-06 |
| 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 | 2018-07-06 |