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..
[138896437]
There was no additional information provided by the initial reporter with regard to patient details, technique used, or specific treatment parameters. The device was evaluated by a cynosure technician and found the unit to be operable within specification. We are unable to determine a root cause for the patient's injury. Due to the severity of the patient's injury, this is a reportable adverse event.
Patient Sequence No: 1, Text Type: N, H10
[138896438]
Patient had a severe internal hemorrhage/hematoma on the abdomen - flanks area following a laser procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2019-00006 |
| MDR Report Key | 8422123 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-14 |
| 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 |