MAUDE Adverse Event Report: CANDELA CORPORATION CANDELA GENTLEMAX PRO; GENTLEMAX PRO (GMAX PRO)

Model Number	9914-00-9035
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Burn(s) (1757); Full thickness (Third Degree) Burn (2696)
Date of Event	05/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has the ability to store treatment data.However, the device can only store up to a certain amount of data.The device was evaluated by downloading the treatment parameters and data loaded in the device internal memory.However, since this patient was treated in (b)(6) and the data downloaded in mid- (b)(6); we did not retrieve any data that could help with the investigation.Technical evaluation of the device is needed to rule out equipment malfunction.
Event or Problem Description
The attending physician reported on a situation where a patient received laser treatment for leg veins (telangiectasia).The patient responded with ring shaped burns in the treated area.After 10 days, deep necrosis including subcutis fatty tissue in the treated area was observed.The patient was receiving treatment for the wound by the attending physician.The wound has been reported healed as of (b)(6) 2016.The physician continued to attend to the patient until the wound was healed.Since this patient was treated in (b)(6) and the treatment data encoded in the software downloaded in mid- (b)(6); we did not retrieve any data that could help with the investigation.Technical evaluation of the device is needed to rule out equipment malfunction.

• Brand Name: CANDELA GENTLEMAX PRO
• Common Device Name: GENTLEMAX PRO (GMAX PRO)
• Manufacturer (Section D): CANDELA CORPORATION; 530 boston post road; wayland, MA
• MDR Report Key: 5987776
• Report Number: 1218402-2016-00009
• Device Sequence Number: 10890219
• Product Code: GEX
• UDI-Device Identifier: 08174950200017
• UDI-Public: 08174950200017
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K133283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9914-00-9035
• Device Catalogue Number: 9914-00-9035
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2016
• Initial Report FDA Received Date: 09/29/2016
• 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