MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-07-13 for SCULPSURE 105-7026-000 manufactured by Cynosure Inc..
[113947785]
Following the laser procedure, patient was given bactrim, keflex, augmentin, mupirocin, and silver sulfadiazine medications for post treatment care. There was no medical intervention associated with the incident. User error was involved in this event since the treatment parameters and technique were not followed per the clinical reference guide. The patient was treated on the under-arm area to address hyperhidrosis and administered a local anesthetic injection (lidocaine) in the under-arm area prior to the laser procedure. The clinical reference guide cautions against performing a sculpsure procedure where the skin was previously affected and "had a previous procedure or surgery in the treatment area that may have resulted in decreased sensation, scar/fibrotic tissue or large scars that may interfere with the treatment. " sculpsure laser treatment must "only be applied to intact, healthy skin, with no evidence of compromised wound healing". The device was not evaluated due to the user error in this event. Burns and bruising are expected side effects experienced from laser treatments, however this is reportable because of the potential for scarring in the affected area.
Patient Sequence No: 1, Text Type: N, H10
[113947786]
Patient experienced a burn on the underarm area following a laser procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2018-00011 |
| MDR Report Key | 7686812 |
| Report Source | CONSUMER |
| Date Received | 2018-07-13 |
| Date of Report | 2018-07-13 |
| Date of Event | 2018-05-23 |
| Date Mfgr Received | 2018-06-15 |
| Device Manufacturer Date | 2016-07-29 |
| Date Added to Maude | 2018-07-13 |
| 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 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 | 2018-07-13 |
| Catalog Number | 105-7026-000 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-07-13 |