MAUDE Adverse Event Report: CANDELA CORPORATION CANDELA GENTLEMAX PRO; GMAX-PRO

Model Number	9914-00-9035
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported a functional issue with the handpiece (delivery system), which has not been received/evaluated.The laser was evaluated by a field service engineer on 08/28/2017 and found within candela specifications.The customer has not responded with status of current condition of patient.Awaiting customer feedback.
Event or Problem Description
On (b)(6) 2017, the (b)(6) account in the us reported on a situation where a patient received laser treatment and responded with a burn on the treated area.

• Brand Name: CANDELA GENTLEMAX PRO
• Common Device Name: GMAX-PRO
• Manufacturer (Section D): CANDELA CORPORATION; 530 boston post road; wayland MA 01778
• MDR Report Key: 6867029
• Report Number: 1218402-2017-00008
• Device Sequence Number: 1408856
• Product Code: GEX
• UDI-Device Identifier: 08174950200017
• UDI-Public: 08174950200017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2017

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: 9914-00-9035
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/14/2017
• 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