MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2018-01-12 for SCULPSURE 100-7026-010 manufactured by Cynosure Inc.
[97273081]
Patient had a laser procedure on the abdomen/flanks/arms area, but complained of rashes on the abdomen/buttocks/thigh area within one month after the procedure. Customer site stated that they had not seen any negative impact on the patient's treated skin per initial post treatment reactions. The patient had medical intervention at the emergency room and primary care physician where it received keflex and norco medication for intervention care. The patient's blood work was evaluated and returned with normal results. The customer site was unresponsive to cynosure's requests for additional treatment/patient details. The patient's condition does not appear to be related to the sculpsure treatment since there weren't any negative reactions on the patient's skin post laser treatment. In addition, the laser treated skin areas do not match the patient's alleged rash affected areas. Since the patient had medical intervention from the emergency room/physician, this is a reportable event.
Patient Sequence No: 1, Text Type: N, H10
[97273082]
Patient developed rashes over the abdomen/thighs/buttocks following a laser procedure
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222993-2018-00003 |
| MDR Report Key | 7187258 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2018-01-12 |
| Date of Report | 2018-01-12 |
| Date of Event | 2017-12-15 |
| Date Mfgr Received | 2017-12-15 |
| Device Manufacturer Date | 2016-03-21 |
| Date Added to Maude | 2018-01-12 |
| 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 | PHYSICIAN ASSISTANT |
| 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 | 2018-01-12 |
| Catalog Number | 100-7026-010 |
| Operator | PHYSICIAN ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-01-12 |