MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-01-05 for SCULPSURE 100-7026-010 manufactured by Cynosure Inc.
[96582683]
Following the laser procedure, patient experienced a burn/blister which resulted in the patient having medical intervention at the emergency room and consulting with a physician. Patient was given aquaphor ointment for post care treatment care. The treatment parameters used in the laser procedure were followed per the clinical reference guide. The patient's treated area is now showing improvement since the laser procedure. The device was evaluated and determined to be operating as intended within specification. Burns/blisters are expected side effects from a laser procedure, however since the patient had medical intervention, this is a reportable event.
Patient Sequence No: 1, Text Type: N, H10
[96582684]
Patient had a burn/blister on the abdomen from a laser procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2018-00001 |
| MDR Report Key | 7169546 |
| Report Source | CONSUMER |
| Date Received | 2018-01-05 |
| Date of Report | 2018-01-05 |
| Date of Event | 2017-12-07 |
| Date Mfgr Received | 2017-12-08 |
| Device Manufacturer Date | 2016-10-24 |
| Date Added to Maude | 2018-01-05 |
| 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 RD |
| 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 | 2018-01-05 |
| Model Number | 100-7026-010 |
| Catalog Number | 100-7026-010 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-01-05 |