MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-08-02 for SCULPSURE 100-7026-010 manufactured by Cynosure Inc.
[81625813]
Patient received aspirin and a sulfa antibiotic for preventative post care treatment. Following the laser procedure, patient had medical intervention at the er and from a vein specialist to treat the affected area. Patient also had an infection, but the cause is unknown. The treatment parameters and technique were followed per the clinical reference guide. The device was evaluated and found to be operating as intended. Patient has now healed from the incident. Inflammation/swelling is an expected side effect from a laser procedure, however since the patient had medical intervention, this is a reportable event.
Patient Sequence No: 1, Text Type: N, H10
[81625814]
Patient had inflammation/swelling on the flanks from a laser procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2017-00035 |
| MDR Report Key | 6761033 |
| Report Source | OTHER |
| Date Received | 2017-08-02 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-06-22 |
| Date Mfgr Received | 2017-07-05 |
| Date Added to Maude | 2017-08-02 |
| 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 |
| 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 | 2017-08-02 |
| 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 RD WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-02 |