MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-02-06 for SCULPSURE 105-7026-000 manufactured by Cynosure Llc.
[178013941]
It was not clear if the organ damage and surgery was related to the treatment or when the surgery was performed. The physician did not mention a relation between sculpture and treatment. A recent device evaluation found the unit operating as intended and working within specification. The device history record confirms that the product passed and met all requirements before releasing. Cynosure is unable to determine how the patient experienced organ damage and surgery following a laser procedure, but we intend to report this as an adverse event.
Patient Sequence No: 1, Text Type: N, H10
[178013942]
Patient is alleging that sculpture caused 'organ damage' and required surgery following a treatment that was done a year ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2020-00004 |
| MDR Report Key | 9677800 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-02-06 |
| 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 | 2020-02-06 |
| Catalog Number | 105-7026-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYNOSURE LLC |
| Manufacturer Address | 5 CARLISLE ROAD WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-06 |