MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-01 for SCULPSURE 100-7026-010 manufactured by Cynosure.
[66607863]
The patient reported pain in the treatment area several days after the procedure. The pain has been reported to be at the level of 5/9 at its worst. This pain has persisted in the months afterward. She also reported the presence of nodules in the treatment area which is believed to be due to fat necrosis. This has been confirmed with ultrasound. Is the product compounded: no. Is the product over-the-counter: no. Event abated after use stopped or dose reduced: no. Even reappeared after reintroduction: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067632 |
| MDR Report Key | 6300065 |
| Date Received | 2017-02-01 |
| Date of Report | 2017-02-01 |
| Date of Event | 2016-08-22 |
| Date Added to Maude | 2017-02-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SCULPSURE |
| Generic Name | SCULPSURE |
| Product Code | PKT |
| Date Received | 2017-02-01 |
| Catalog Number | 100-7026-010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYNOSURE |
| Manufacturer Address | WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-01 |