MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-03-14 for SCULPSURE 105-7026-000 manufactured by Cynosure Inc..
[138840360]
The patient was then provided with cold packs, antiseptic creams, and local anesthetics for post treatment care. There was no additional information provided by the initial reporter with regard to patient details or treatment parameters. The device was evaluated by a cynosure technician and found the unit to be operable working within specification. We are unable to determine a root cause for the patient's injury. Burns are expected side effects from laser treatment, but due to the severity of a 3rd degree burn, this is a reportable adverse event.
Patient Sequence No: 1, Text Type: N, H10
[138840361]
Patient had a 3rd degree burn on the abdomen-flanks area following a laser procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2019-00005 |
| MDR Report Key | 8422103 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-14 |
| Date of Event | 2018-05-28 |
| Date Mfgr Received | 2018-12-28 |
| Device Manufacturer Date | 2016-01-13 |
| Date Added to Maude | 2019-03-14 |
| 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 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 | 2019-03-14 |
| Catalog Number | 105-7026-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-14 |