MAUDE Adverse Event Report: CANDELA CORPORATION GL-PRO U

Model Number	9914-00-9030
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No information from the facility as of 3/28/2018.
Event or Problem Description
On (b)(6) 2018, the (b)(6) account in us reported that patient response to treatment with burn.We tried to reach this facility numerous times to obtain more information on patient condition or type of injury without any success.Therefore, due to lack of any information from the facility, we are submitting this mdr as a precaution.

• Brand Name: GL-PRO U
• Common Device Name: GL-PRO U
• Manufacturer (Section D): CANDELA CORPORATION; 530 boston post road; wayland MA 01778
• MDR Report Key: 7379680
• Report Number: 1218402-2018-00006
• Device Sequence Number: 16406908
• Product Code: GEX
• UDI-Device Identifier: 08174950200086
• UDI-Public: 08174950200086
• Combination Product (Y/N): N
• PMA/510(K) Number: K024371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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: Health Professional
• Device Model Number: 9914-00-9030
• Device Catalogue Number: 9914-00- 9030
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/28/2018
• 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