MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-02 for SCULPSURE 100-7026-010 manufactured by Cynosure, Inc.
[68963437]
The customer reported that a patient had excess swelling after sculpsure treatment on the thighs. The patient was given antibiotics as medical intervention. There is no long term injury anticipated as it is reported that the patient is improving. The device was evaluated and was operating within specifications. Swelling and nodules are known side effects of sculpsure treatment. This is reportable due to the medical intervention of the antibiotics.
Patient Sequence No: 1, Text Type: N, H10
[68963438]
The patient had excess swelling on her thighs after sculpsure treatment. The patient received antibiotics as medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2017-00014 |
| MDR Report Key | 6373635 |
| Report Source | USER FACILITY |
| Date Received | 2017-03-02 |
| Date of Report | 2017-03-02 |
| Date of Event | 2016-11-23 |
| Date Mfgr Received | 2017-02-02 |
| Date Added to Maude | 2017-03-02 |
| 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 ROAD |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal | 01886 |
| Manufacturer G1 | CYNOSURE, INC |
| Manufacturer Street | 5 CARLISLE ROAD |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 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 | 2017-03-02 |
| Catalog Number | 100-7026-010 |
| Device Availability | Y |
| 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 | 2017-03-02 |