SCULPSURE UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-22 for SCULPSURE UNK manufactured by Cynosure.

Event Text Entries

[78495898] I have had two treatments using a device called sculpsure. It is said to be an fda-approved laser treatment for fat reduction. The device is apparently made by a company called cynosure in (b)(4). The treatments were administered by (b)(6). The treatments, costing (b)(6), did nothing to reduce or eliminate fat in the area treated. The treatments left me with hard lumps under my skin, which haven't gone away after three months. I don't know if the treatment and machine was used correctly or not. The clinic took a series of photos before both treatments and they should clearly show there was no effect whatsoever from the treatments. I am concerned that this so-called "fda approved" device does not perform as advertised, and has this unwanted side-effect that can't be healthy.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5070618
• MDR Report Key: 6666806
• Date Received: 2017-06-22
• Date of Report: 2017-06-22
• Date of Event: 2017-04-10
• Date Added to Maude: 2017-06-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: SCULPSURE
• Generic Name: SCULPSURE
• Product Code: PKT
• Date Received: 2017-06-22
• Model Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CYNOSURE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2017-06-22