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

Model Number	POLLOGEN LEGEND+
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	01/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that one (1) patient sustained an untypical reaction of unknown severity following treatment with a pollogen legend+ rf device.No report of medical intervention was received from the user facility other than 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: 6365713
• Report Number: 1720381-2017-00008
• Device Sequence Number: 13697037
• Product Code: GEI
• UDI-Device Identifier: 07290016586008
• UDI-Public: 07290016586008
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2017
• 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: 02/03/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/28/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2017
• 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