SCULPSURE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-29 for SCULPSURE manufactured by Cynosure Inc..

Event Text Entries

[109644027] I had the sculpsure procedure and was told it would be painless and wasn't told of any side effects. After the procedure, two nodules developed on the skin on my thighs. I called and emailed cynosure several times and they are completely unhelpful. They at first said, just massage it and it will go away. No 11 months in the plastic surgeon where i had the procedure tells me it's scar tissue and would need to be injected to try and get rid of it, but that is not a guarantee. I was hoping since cynosure was fda approved, that they would be able to further help me. I spoke with someone named (b)(4) for the third time today at cynosure and she is trying to put this back on the doctor where i had the procedure. She had no suggestions for what can be done to get rid of these nodules. It sounded like they had lots of other complaints of similar cases. Also, as a side note, they advertise these procedure as virtually painless, but it is beyond painful it is a complete lie that this isn't painful.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5077529
• MDR Report Key: 7553342
• Date Received: 2018-05-29
• Date of Report: 2018-05-24
• Date of Event: 2017-06-23
• Date Added to Maude: 2018-05-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• 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: 2018-05-29
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CYNOSURE INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2018-05-29