MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-25 for SCULPSURE 100-7026-010 manufactured by Cynosure Inc.
[76012557]
Patient received (b)(4) for preventative post care treatment following the laser procedure, but was prescribed antibiotics as a medical intervention from a physician to treat the affected area. The patient's blistered area is expected to scar, resulting in a permanent injury. User error was involved in this incident because the operator treated the patient's flanks where it had areas of skin folds and was close to the hip bone. It is cautioned in the clinical guidelines that treating over these areas can result in adverse skin effects: "do not treat over areas of deep, thick skin folds where the applicator may not cool the area adequately. Discomfort and adverse skin effects may result. " and "do not treat over scars or bony areas such as the hips or ribs. Discomfort and adverse skin effects may result". The device was evaluated and found to be operating as intended. 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.
Patient Sequence No: 1, Text Type: N, H10
[76012558]
Patient developed a large blister from a laser procedure on the flanks area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2017-00020 |
| MDR Report Key | 6592779 |
| Report Source | CONSUMER |
| Date Received | 2017-05-25 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-04-19 |
| Date Mfgr Received | 2017-04-27 |
| Date Added to Maude | 2017-05-25 |
| 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 | 2017-05-25 |
| 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 | 2017-05-25 |