MAUDE Adverse Event Report: POLLOGEN LTD. POLLOGEN LEGEND +; POLLOGEN LEGEND+

Model Number	POLLOGEN LEGEND+
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that one (1) patient sustained burns and blisters to the leg following treatment with a pollogen legend + rf device.No report of medical intervention was received from the user facility other than the initial report.Additionally, the user facility suggested the use of bacitracin, an over the counter antibiotic ointment to the patient.
Event or Problem Description
A user facility reported that one patient sustained burns and blisters to the leg following treatment with a pollogen legend + rf device.No report of medical intervention was received from the user facility other than the initial report.Additionally, the user facility suggested the use of bacitracin, an over the counter antibiotic ointment to the patient.The legal manufacturer ((b)(4)) was notified of the initial report.

• Brand Name: POLLOGEN LEGEND +
• Common Device Name: POLLOGEN LEGEND+
• Manufacturer (Section D): POLLOGEN LTD.; 6 kaufman st.; tel aviv, 68012 98; IS 6801298
• MDR Report Key: 6365806
• Report Number: 1720381-2017-00007
• Device Sequence Number: 659231
• Product Code: GEI
• UDI-Device Identifier: 07290016586008
• UDI-Public: 07290016586008
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2017
• Report Date (Section F): 02/28/2017

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: Other
• Device Model Number: POLLOGEN LEGEND+
• Device Catalogue Number: 30009000U
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/09/2016
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 02/28/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2017
• Supplement Report FDA Received Date: 04/13/2017
• 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