MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-06-15 for SCULPSURE 100-7026-010 manufactured by Cynosure Inc.
[47487084]
Patient experienced a blister on its flank area from a laser treatment. Patient received medical intervention from its physician and was prescribed medication for post care treatment. User error contributed to this incident as well because the patient was treated over skin folds on the flank, which is not recommended per the clinical guidelines. This can lead to inadequate contact cooling of the treatment area. Blisters are expected side effects from laser treatments, but this is reportable because the patient received medical intervention. There was no problem found with the device, operated as intended.
Patient Sequence No: 1, Text Type: N, H10
[47487085]
Patient's burn from a laser procedure required medical intervention from a physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2016-00023 |
| MDR Report Key | 5727750 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-06-15 |
| Date of Report | 2016-06-15 |
| Date of Event | 2016-05-06 |
| Date Mfgr Received | 2016-05-19 |
| Date Added to Maude | 2016-06-15 |
| 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 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 | 2016-06-15 |
| 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 | 2016-06-15 |