MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-03 for SLT II CELLULAZE manufactured by .
[20371712]
Patient had treatment for lipolysis 2 years ago (2013), but did not submit a complaint to cynosure until (b)(6) 2015. The event involved the patient having blue, bruised pigmentation and dropped buttocks.
Patient Sequence No: 1, Text Type: D, B5
[20517696]
Patient reported having lipolysis treatment 2 years ago (2013) using the cellulaze device. Patient experienced blue, bruising pigmentation and drooped buttocks. Cynosure became aware on (b)(6) 2015 and assessed the patient incident/laser device used. The laser was found to be operational and working within established specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222993-2015-00010 |
| MDR Report Key | 4660173 |
| Report Source | 05 |
| Date Received | 2015-04-03 |
| Date of Report | 2015-04-02 |
| Date of Event | 2015-03-04 |
| Date Mfgr Received | 2015-03-04 |
| Date Added to Maude | 2015-04-07 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLT II CELLULAZE |
| Generic Name | LASER |
| Product Code | OYW |
| Date Received | 2015-04-03 |
| Model Number | CELLULAZE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-04-03 |