MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-05 for SCULPSURE 100-7026-010 105-7026-000 manufactured by Cynosure Inc..
[134987278]
In this incident, patient experienced a blister on the abdomen - flanks area following a laser procedure with the sculpsure. User error was involved in this incident since it was also determined that the treatment was performed over creases in the skin/uneven tissue upon the flanks. The clinical reference guide was not followed as it cautions: "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. " the patient sought medical intervention at a burn center where the wound was debrided and received enzymatic medication cream. Blisters are expected side effects from laser treatments, however this event is reportable because the patient had medical intervention.
Patient Sequence No: 1, Text Type: N, H10
[134987279]
Patient had medical intervention following a laser procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2019-00002 |
| MDR Report Key | 8304615 |
| Report Source | CONSUMER |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-05 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2019-01-11 |
| Device Manufacturer Date | 2017-11-27 |
| Date Added to Maude | 2019-02-05 |
| 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 ROAD |
| 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 | 2019-02-05 |
| Model Number | 100-7026-010 |
| Catalog Number | 105-7026-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-02-05 |