MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-25 for SCULPSURE 100-7026-010 manufactured by Cynosure Inc.
[83651037]
There was no medication associated with this incident. Following the laser procedure, patient had medical intervention via physical therapy to treat the affected area. The patient declined to share medical records with the customer site. Cynosure has attempted multiple times to contact the customer site for additional information, but they were unresponsive. The device was evaluated and found to be operating as intended. Numbness is an expected side effect from a laser procedure. Since the patient had medical intervention, this is a reportable event.
Patient Sequence No: 1, Text Type: N, H10
[83651038]
Patient had numbness in the arms from a laser procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2017-00040 |
| MDR Report Key | 6820671 |
| Report Source | CONSUMER |
| Date Received | 2017-08-25 |
| Date of Report | 2017-08-25 |
| Date of Event | 2017-05-08 |
| Date Mfgr Received | 2017-07-27 |
| Date Added to Maude | 2017-08-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 5 CARLISLE RD |
| 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 | SCULPSURE |
| Generic Name | SCULPSURE |
| Product Code | PKT |
| Date Received | 2017-08-25 |
| Catalog Number | 100-7026-010 |
| 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. Other | 2017-08-25 |