MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-12-15 for SCULPSURE 100-7026-010 manufactured by Cynosure Inc.
[62418341]
Patient was admitted to a hospital for 3 days, where it received an endoscopy procedure indicating it had broken capillaries. Physician stated heat from the laser procedure caused the broken capillaries. However, the device's mechanism of action does not penetrate beyond the subcutaneous fat layer so the impact of the treatment would not contribute to capillary damage. The device was evaluated and found to be operating as intended. Patient has since healed from this incident. This incident is reportable since the patient had medical intervention at the hospital.
Patient Sequence No: 1, Text Type: N, H10
[62418342]
Patient developed experienced vomiting / diarrhea (bloody) following a laser procedure on the abdomen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2016-00060 |
| MDR Report Key | 6175264 |
| Report Source | CONSUMER |
| Date Received | 2016-12-15 |
| Date of Report | 2016-12-13 |
| Date of Event | 2016-11-03 |
| Date Mfgr Received | 2016-11-14 |
| Date Added to Maude | 2016-12-15 |
| 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 Contact | CYNOSURE INC |
| Manufacturer Street | 5 CARLISLE RD. |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal | 01886 |
| Manufacturer Phone | 9783678736 |
| 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 | 2016-12-15 |
| 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. Hospitalization | 2016-12-15 |