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

Model Number	NUERA TIGHT
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 an adverse event report on a patient who sustained scabs following treatment with bios nuera device.No initial report on serious injury was received.The customer reported on bipolar hp shocking sensation.The service engineer suspects the most likely cause for the issue with the gel.The customer reports that they have used many different forms of gel and it still shocks people.

• Brand Name: NUERA TIGHT
• Common Device Name: FAMILY OF RADIOFREQUENCY SYSTEM
• Manufacturer (Section D): BIOS SRL; via guido rossa, 10/12; vimodrone, 20090 ; IT 20090
• MDR Report Key: 10754647
• Report Number: 1720381-2020-00013
• Device Sequence Number: 1125706
• Product Code: PBX
• UDI-Device Identifier: 08052049500104
• UDI-Public: 08052049500104
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2020
• Report Date (Section F): 10/29/2020

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: NUERA TIGHT
• Device Catalogue Number: GA-5000050:
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/02/2020
• Device Age: 2 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2020
• 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
• Patient Age: 50 YR
• Date Report Sent to FDA: 10/29/2020