MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-08-25 for SCULPSURE 100-7026-010 manufactured by Cynosure Inc.
[53037056]
Patient experienced nodules on flanks from laser treatment with the sculpsure. These nodules were surgically removed. There was no medication prescribed in this incident and treatment parameters were within clinical guidelines. Nodules are expected side effects from this laser treatment, however due to tenderness the nodules were surgically removed. The patient's condition has since improved. There was no problem found with the device, operated as intended. This is a reportable incident because the patient had medical intervention.
Patient Sequence No: 1, Text Type: N, H10
[53037057]
Patient had medical intervention from a laser procedure on the flanks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2016-00037 |
| MDR Report Key | 5904612 |
| Report Source | CONSUMER |
| Date Received | 2016-08-25 |
| Date of Report | 2016-08-25 |
| Date of Event | 2016-02-04 |
| Date Mfgr Received | 2016-07-26 |
| Date Added to Maude | 2016-08-25 |
| 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 | 2016-08-25 |
| 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 | 2016-08-25 |