MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-10-28 for SCULPSURE 100-7026-010 manufactured by Cynosure Inc.
[58661271]
Patient was given levaquin as intervention medication and topical antibiotic mupirocin ointment for preventative post care treatment. User of device treated on patient's skin area that was previously affected from a prior surgery. This treatment, however, was not performed per the clinical guidelines since it contraindicates against performing laser procedures upon skin where a patient had a previous procedure/surgery. This incident led to the patient developing an infection on the affected treatment area. Customer site declined a device evaluation from cynosure, but informed that the device was operating without any problems. This event is reportable because the patient had intervention medication. Patient is now healing well. Customer declined and user error.
Patient Sequence No: 1, Text Type: N, H10
[58661272]
Patient had intervention medication for a burn that developed on its abdomen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2016-00050 |
| MDR Report Key | 6064302 |
| Report Source | CONSUMER |
| Date Received | 2016-10-28 |
| Date of Report | 2016-10-26 |
| Date of Event | 2016-09-28 |
| Date Mfgr Received | 2016-09-28 |
| Date Added to Maude | 2016-10-28 |
| 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 Contact | CYNOSURE INC |
| Manufacturer Street | 5 CARLISLE RD. |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal | 01886 |
| Manufacturer Phone | 9783678736 |
| 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 | 2016-10-28 |
| 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 | 2016-10-28 |