MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-08-04 for SLT II manufactured by Cynosure Inc.
[6640451]
Patient experienced a full thickness burn on its left inner thigh from a laser procedure.
Patient Sequence No: 1, Text Type: D, B5
[14235469]
Patient was prescribed polysporin medication and a compression garment for preventative care. Treatment parameters were within clinical guidelines. There was no problem found with the device and operated within specification. However this is a reportable event because a full thickness burn is a serious injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222993-2015-00035 |
| MDR Report Key | 4965517 |
| Report Source | 05 |
| Date Received | 2015-08-04 |
| Date of Report | 2015-08-04 |
| Date of Event | 2015-04-09 |
| Date Mfgr Received | 2015-07-09 |
| Date Added to Maude | 2015-08-04 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | SLT II |
| Generic Name | SLT II |
| Product Code | OYW |
| Date Received | 2015-08-04 |
| 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. Deathisabilit | 2015-08-04 |