MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-10-07 for SCULPSURE 100-7026-010 manufactured by Cynosure Inc.
[56804409]
The patient experienced nodules on their abdomen after laser treatment with sculpsure. The treatment parameters were within clinical guidelines. The patient is undergoing acoustic wave therapy to attempt to resolve nodules. Nodules are an expected side effect from the treatment. Upon evaluation, the device was found to be working within specifications and no problems were found. This is reportable because the patient received medical intervention.
Patient Sequence No: 1, Text Type: N, H10
[56804410]
The patient reported presence of nodules post 6 months after treatment. The patient is receiving weekly acoustic wave treatments to resolve nodules.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2016-00047 |
| MDR Report Key | 6010951 |
| Report Source | USER FACILITY |
| Date Received | 2016-10-07 |
| Date of Report | 2016-10-07 |
| Date of Event | 2016-04-15 |
| Date Mfgr Received | 2016-09-12 |
| Date Added to Maude | 2016-10-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 5 CARLISLE ROAD |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal | 01886 |
| Manufacturer G1 | CYNOSURE INC |
| Manufacturer Street | 5 CARLISLE ROAD |
| Manufacturer City | WESTFORD MA 01886 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 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 | 2016-10-07 |
| Catalog Number | 100-7026-010 |
| Operator | PHYSICIAN |
| Device Availability | * |
| 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. Required No Informationntervention | 2016-10-07 |