MAUDE Adverse Event Report: CYNOSURE INC. SCULPSURE

Model Number	100-7026-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cynosure's clinical team was unable to obtain patient/treatment details to further investigate this incident as the customer site was unresponsive to multiple requests for information.A recent device evaluation found the unit operating as intended and working within specification.Cynosure is unable to determine how the patient experienced a kidney infection following a laser procedure, but we intend to report this as an adverse event.
Event or Problem Description
Patient claimed of an alleged kidney infection following a laser procedure.(patient 1 of 2).

• Brand Name: SCULPSURE
• Common Device Name: SCULPSURE
• Manufacturer (Section D): CYNOSURE INC.; 5 carlisle road; westford MA 01886
• MDR Report Key: 8031044
• Report Number: 1222993-2018-00025
• Device Sequence Number: 1382014
• Product Code: PKT
• UDI-Device Identifier: 00841494100032
• UDI-Public: (01)00841494100032(11)170717
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 100-7026-010
• Device Catalogue Number: 105-7026-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other