MAUDE Adverse Event Report: BIOS SRL NUERA TIGHT; RADIO-FREQUENCY SKIN CONTURING SYSTEM

Model Number	NUERA TIGNT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained burn following treatment by nuera 1.2 device.Customer reported when used 70mm pad, the customer got burn during treatment, temperature is the system is too low 37 degrees celsius.
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility directly.Attempts by emails and phone calls have been made to obtain; patient treatment settings, patient information, patient photo.The device nuera 1.2 ga-5200000us:nt1451-21g-224 was installed on (b)(6) 2021 and it's still on warranty.This case was escalated to tech.Support and they reported: "called customer, left a message.This sounds like it needs to be a safety case.I recommend ordering a new electrode ø 70 capacitive (b)(4)." (b)(6) 2022 order shipped for delivery # 813388584.Since, there is no proven evidence that the device malfunction was the suspected cause of the adverse event because customer did not initiated service visit for testing of this device and low temperature means less energy and not likely can lead to serious injury with permanent impairment.Anyway, per technical support recommendation, replacement part was sent to the customer.Since lumenis is not the manufacturer of the device, which was used during this procedure, this case is not reportable from technical aspect by lumenis.However, lumenis has informed the legal manufacturer, bios, on this adverse event, and has sent them all the relevant information regarding to investigation process, findings and conclusions.Lumenis could not evaluate the rate of injury because we have not received yet the incident form (if) from facility.Due to lack of information (no incident form received), lumenis is reporting the event in an 'abundance of caution' from clinical aspect.Should additional significant information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.

• Brand Name: NUERA TIGHT
• Common Device Name: RADIO-FREQUENCY SKIN CONTURING SYSTEM
• Manufacturer (Section D): BIOS SRL; via guido rossa 10/12; vimodrone, 20090 ; IT 20090
• MDR Report Key: 14468786
• Report Number: 3020611964-2022-00001
• Device Sequence Number: 14678475
• Product Code: PBX
• UDI-Device Identifier: 08052049500111
• UDI-Public: 08052049500111
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/23/2022
• Report Date (Section F): 05/23/2022

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 TIGNT
• Device Catalogue Number: GA-50000US
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/25/2022
• Device Age: 8 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/23/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 05/23/2022