MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-11-01 for SCULPSURE 100-7026-010 105-7026-000 manufactured by Cynosure Inc..
[125903299]
Cynosure's clinical team was unable to obtain patient/treatment details to further investigate this incident as the customer site was unresponsive to multiple requests for information. A recent device evaluation found the unit operating as intended and working within specification. Cynosure is unable to determine how the patient experienced a kidney infection following a laser procedure, but we intend to report this as an adverse event.
Patient Sequence No: 1, Text Type: N, H10
[125903300]
Patient claimed of an alleged kidney infection following a laser procedure. (patient 1 of 2).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2018-00025 |
| MDR Report Key | 8031044 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-11-01 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-10-05 |
| Date Mfgr Received | 2018-10-05 |
| Device Manufacturer Date | 2017-07-25 |
| Date Added to Maude | 2018-11-01 |
| 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 | 2018-11-01 |
| Model Number | 100-7026-010 |
| Catalog Number | 105-7026-000 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-01 |