MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-11-17 for SCULPSURE 100-7026-010 manufactured by Cynosure Inc.
[92460362]
Following the laser procedure, the thigh area revealed varicose veins, so patient had medical intervention with a vein specialist. The specialist informed the patient that it has a severe venous deficiency and recommended surgery to resolve the issue. There is no evidence that the sculpsure procedure caused the varicose veins to appear, rather this may be a pre-existing condition for the patient. The treatment parameters and technique were followed per the clinical reference guide. The device was evaluated and operated as intended. Pain/discomfort are expected side effects from a laser procedure, however since the patient had medical intervention, this is a reportable event.
Patient Sequence No: 1, Text Type: N, H10
[92460363]
Patient had soreness/swelling on the inner thighs from a laser procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2017-00046 |
| MDR Report Key | 7041791 |
| Report Source | CONSUMER |
| Date Received | 2017-11-17 |
| Date of Report | 2017-11-17 |
| Date of Event | 2017-09-13 |
| Date Mfgr Received | 2017-10-27 |
| Date Added to Maude | 2017-11-17 |
| 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 RD |
| 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 | 2017-11-17 |
| 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 | 2017-11-17 |