MAUDE Adverse Event Report: BIOS SRL NUERA; FAMILY OF RADIOFREQUENCY SYSTEM

Model Number	NUERA
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
Lumenis received a report of a patient feeling a shocking sensation and suffered from a blister following treatment with bios nuera device.

• Brand Name: NUERA
• Common Device Name: FAMILY OF RADIOFREQUENCY SYSTEM
• Manufacturer (Section D): BIOS SRL; via guido rossa, 10/12; vimodrone, 20090 ; IT 20090
• MDR Report Key: 11920602
• Report Number: 1720381-2021-00004
• Device Sequence Number: 860946
• Product Code: PBX
• UDI-Device Identifier: 08052049500104
• UDI-Public: 08052049500104
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/02/2021
• Report Date (Section F): 06/02/2021

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: NUERA
• Device Catalogue Number: GA-5000020
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/11/2021
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2021
• 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