MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-09-12 for SCULPSURE 100-7026-010 105-7026-000 manufactured by Cynosure Inc..
[120004971]
In this incident, patient experienced a blister-burn on the abdomen area following a laser procedure with the sculpsure. However, it was determined that the burn was not due to the laser procedure, but rather from patient error. The patient had applied an ice pack directly onto the laser treated area, which resulted in a blister/burn. As a result, the patient decided to visit the er for care. There is no additional information regarding this form of intervention. The customer site indicated there were no adverse effects as a result of the laser treatment on the day of the procedure. They provided an oral antibiotic for preventative care. The treatment parameters applied in the procedure were followed per the clinical reference guide. Though this patient impact was determined to be unrelated to the effects of the laser treatment, this is being reported because the patient had medical intervention at the emergency room.
Patient Sequence No: 1, Text Type: N, H10
[120004972]
Patient had medical intervention following a laser procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2018-00018 |
| MDR Report Key | 7870261 |
| Report Source | CONSUMER |
| Date Received | 2018-09-12 |
| Date of Report | 2018-09-12 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-08-13 |
| Device Manufacturer Date | 2017-03-09 |
| Date Added to Maude | 2018-09-12 |
| 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 |
| 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 | 2018-09-12 |
| Model Number | 100-7026-010 |
| Catalog Number | 105-7026-000 |
| 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 | 2018-09-12 |