MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-29 for SLT II WITH CELLULAZE 105-0056-810 manufactured by Cynosure, Inc..
[3527221]
Patient allegedly developed blisters 2-3 days post treatment. Patient condition is being treated with topical prescription medication.
Patient Sequence No: 1, Text Type: D, B5
[10795922]
An on site evaluation of the laser was performed and the laser was performing as expected, no malfunction identified. Blisters are known as possible side effect of laser procedures and identified as such in product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222993-2013-00004 |
| MDR Report Key | 3139461 |
| Report Source | 05 |
| Date Received | 2013-05-29 |
| Date of Report | 2013-05-29 |
| Date of Event | 2013-04-30 |
| Date Mfgr Received | 2013-04-30 |
| Date Added to Maude | 2013-06-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 5 CARLISLE ROAD |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal | 01886 |
| Manufacturer Phone | 9783678736 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLT II WITH CELLULAZE |
| Generic Name | DERMATOLOGY LASER SYSTEM |
| Product Code | OYW |
| Date Received | 2013-05-29 |
| Model Number | 105-0056-810 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYNOSURE, INC. |
| Manufacturer Address | WESTFORD MA 01886 US 01886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-05-29 |