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 2019-07-12 for ICON R105-2500-000 manufactured by Cynosure Llc.
| Report Number | 1222993-2019-00011 |
| MDR Report Key | 8786766 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-07-12 |
| Date of Report | 2019-07-12 |
| Date of Event | 2019-06-13 |
| Date Mfgr Received | 2019-06-13 |
| Device Manufacturer Date | 2012-03-28 |
| Date Added to Maude | 2019-07-12 |
| 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 | ICON |
| Generic Name | ICON |
| Product Code | PKT |
| Date Received | 2019-07-12 |
| Catalog Number | R105-2500-000 |
| Device Availability | Y |
| Device Age | DA |
| 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; 2. Deathisabilit | 2019-07-12 |