MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-04-07 for SCULPSURE 100-7026-010 manufactured by Cynosure Inc.
[72141238]
There was no medication or treatment information available for this particular incident. However, the patient did receive an intervention procedure which involved the blister site being excised and redressed to improve healing. Blisters are expected side effects from laser treatment, however based on the degree of the patient's injury requiring an intervention, this is a reportable event. The device was evaluated and found to be operating as intended.
Patient Sequence No: 1, Text Type: N, H10
[72141239]
Patient developed a blister from a laser procedure on the right side of the flanks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2017-00018 |
| MDR Report Key | 6472965 |
| Report Source | CONSUMER |
| Date Received | 2017-04-07 |
| Date of Report | 2017-04-07 |
| Date Mfgr Received | 2017-03-10 |
| Date Added to Maude | 2017-04-07 |
| 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 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 | 2017-04-07 |
| 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 | 2017-04-07 |