MAUDE Adverse Event Report: CANDELA CORPORATION CANDELA GYAG-PRO U LASER

Model Number	9914-00-9020
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	08/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The laser system was evaluated on 08/07/2017 and found to be operating in-specification.Use-error and excessive energy is suspected.
Event or Problem Description
On (b)(6) 2017 the (b)(6) laser and med spa in (b)(6) reported that patient who received 2nd laser hair removal treatment had responded with burns and blisters on treated area.

• Brand Name: CANDELA GYAG-PRO U LASER
• Common Device Name: GYAG-PRO U
• Manufacturer (Section D): CANDELA CORPORATION; 530 boston post road; wayland MA 01778
• MDR Report Key: 6797694
• Report Number: 1218402-2017-00007
• Device Sequence Number: 19025544
• Product Code: GEX
• UDI-Device Identifier: 08174950200048
• UDI-Public: 08174950200048
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K033172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2017

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: 9914-00-9020
• Device Catalogue Number: 9914-00-9020
• 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: 08/03/2017
• Initial Report FDA Received Date: 08/16/2017
• 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