MAUDE Adverse Event Report: CANDELA CORPORATION PROFOUND SYSTEM; ELECTROSURGICAL UNIT AND ACCESSORIES

Model Number	FG70523
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	01/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplimental mdr will be submitted upon completion of the investigation.
Event or Problem Description
Customer reported to technical service that a (b)(6) year old female patient received "radio frequency profound treatment" to the face and neck area on (b)(6) 2019.Treatment included use of dermal handpiece; 651 pulses were administered in total, set at 67 degrees celsius for a 3 second duration at 3 mm pulse spacing on the patient.There was no immediate post-treatment reaction.Upon four and eight week post-treatment follow up, patient had developed acne-like scarring or skin pitting on her lower face and neck.There was no medical intervention, no medications prescribed.Doctor indicates patient will need laser resurfacing.
Additional Manufacturer Narrative
An evaluation of the device found no problems with the device and confirmed it to be operating within published specifications.The field service engineer (fse) performed calibration verification procedures and verified unit to be operating within specifications.Cause cannot be traced to device.No new risks or hazards identified with this complaint.Scarring is listed in the operators manual as a transient side effect that should clear with time.Clinical education reached out the customer and provided additional training to the site.

• Brand Name: PROFOUND SYSTEM
• Common Device Name: ELECTROSURGICAL UNIT AND ACCESSORIES
• Manufacturer (Section D): CANDELA CORPORATION; 530 boston post rd; wayland MA 01778
• MDR Report Key: 8456148
• Report Number: 3003772750-2019-00002
• Device Sequence Number: 3057771
• Product Code: GEI
• UDI-Device Identifier: 07290109952444
• UDI-Public: 07290109952444
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2019

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: Health Professional
• Device Model Number: FG70523
• Device Catalogue Number: FG70523
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 08/02/2019
• 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: Disability
• Patient Age: 56 YR