MAUDE Adverse Event Report: CANDELA CORPORATION CANDELA GMAX PRO

Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rep visited the account to evaluate system.System was working to specifications.We received photos of the patient before and after and identified 1 area that can be a second degree burn.Because it is not clear if this is second or first degree burn, as a precaution, we reporting this as an mdr.
Event or Problem Description
On (b)(6) 2018 a patient that was treated by (b)(6) in (b)(6) reported that they responded to laser treatment with burns.

• Brand Name: CANDELA GMAX PRO
• Common Device Name: GMAX PRO
• Manufacturer (Section D): CANDELA CORPORATION; 530 boston post road; wayland MA 01778
• MDR Report Key: 7441306
• Report Number: 1218402-2018-00009
• Device Sequence Number: 1718339
• Product Code: GEX
• UDI-Device Identifier: 08174950200017
• UDI-Public: 08174950200017
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/18/2018
• 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