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 2018-06-15 for SCULPSURE 100-7026-010 105-7026-000 manufactured by Cynosure Inc..
[111165049]
There was no medication or intervention associated with this event. User error was involved since the operator performed the sculpsure laser treatment over an existing tattoo near the hip bone, which is cautioned against in the clinical reference guide. This resulted in the tattoo area receiving a burn that may develop into a potential scar. Per the sculpsure clinical reference guide: "when treating over a tattoo, there is an increased risk of adverse skin effects and discomfort if the applicator(s) is not in full contact with the skin" and "do not treat over scars or bony area such as hips or ribs. Discomfort or adverse skin effects may occur". As a result, there was a loss of proper contact with the skin during the treatment and prevented adequate cooling from being delivered to the treated areas. The device was not evaluated due to the user error in this incident. Burns are expected side effects from laser treatments, however this is reportable because of the potential for scarring.
Patient Sequence No: 1, Text Type: N, H10
[111165050]
Patient experienced a burn on the flanks area following a laser procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2018-00010 |
| MDR Report Key | 7605085 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-06-15 |
| Date of Report | 2018-06-15 |
| Date of Event | 2018-05-10 |
| Date Mfgr Received | 2018-05-18 |
| Device Manufacturer Date | 2016-12-29 |
| Date Added to Maude | 2018-06-15 |
| 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 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 | 2018-06-15 |
| Model Number | 100-7026-010 |
| Catalog Number | 105-7026-000 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-06-15 |