MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-17 for SCULPSURE 100-7026-010 manufactured by Cynosure Inc.
[82923476]
Patient received silvadene cream for preventative post care treatment healing. Treatment parameters were not followed per the clinical reference guide due to user error in the technique. The operator of the device treated over a skin fold, which is cautioned by the device's clinical reference guide stating: "do not treat over areas of deep, thick skin folds where the applicator may not cool the area adequately. Discomfort and adverse skin effects may result. " since the user error contributed to this event, the device was not evaluated. Blisters are expected side effects from laser procedures, but due to the severity of the patient's blister, this will result in a scar. This is a reportable event.
Patient Sequence No: 1, Text Type: N, H10
[82923477]
Patient had a severe blister on the flanks from a laser procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2017-00037 |
| MDR Report Key | 6800904 |
| Report Source | CONSUMER |
| Date Received | 2017-08-17 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-03-27 |
| Date Mfgr Received | 2017-07-19 |
| Date Added to Maude | 2017-08-17 |
| 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 |
| 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 | 2017-08-17 |
| Catalog Number | 100-7026-010 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-08-17 |