MAUDE Adverse Event Report: BIOS SRL NUERA TIGHT 1.2; RADIO-FREQUENCY SKIN CONTURING SYSTEM

Model Number	NUERA TIGHT 1.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blister (4537)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
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 and patient photo.No incident form or patient photo has been received in lumenis.The device was installed on (b)(6) 2021 and is billable.No pm was performed since then based on device service history.Lumenis highly recommends an annual pm check in a timely manner to assure continued proper operation of the device.Initiative and payment for that lies on customer's responsibility.According to the technical support team, if the shielding is damaged or worn out in any way, it must be replaced by the user facility.The customer has not reported any device errors, and the system appears to be functioning properly.For the nuera 1.2 device, lumenis recommends using disposable grounding pads only.The technical support team has made several attempts to contact the customer to discuss the reported event and review technical data.However, the customer has been largely unresponsive.According to the ce, the customer continues to use the device without any issues.The ce advised transitioning from reusable grounding pads to disposable ones, but no response has been received to date.Device malfunction wasn't the suspected cause of the adverse event.The user manual includes the following instruction: "discard the single-use return plates after each patient use.Use only the single-use plates provided by lumenis." while the information received to date does not confirm that a serious injury nor malfunction had occurred, because of the lack of information lumenis is reporting the event in an 'abundance of caution'.Should additional significant information become available, the complaint record will be updated accordingly, and a follow-up medwatch report will be submitted.Lumenis is not the manufacturer of the nuera tight device which was used during this procedure, lumenis has forwarded the information of this event to the legal manufacturer and is closing this complaint.
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained blister using reusable return plate following treatment by nuera device.According to the patient, the reusable grounding pad fel hot during the treatment.

• Brand Name: NUERA TIGHT 1.2
• Common Device Name: RADIO-FREQUENCY SKIN CONTURING SYSTEM
• Manufacturer (Section D): BIOS SRL; via guido rossa, 10/12; vimodrone, ita 20055 ; IT 20055
• MDR Report Key: 22792969
• Report Number: 3020611964-2025-00009
• Device Sequence Number: 18303571
• Product Code: PBX
• UDI-Device Identifier: 08052049500111
• UDI-Public: 08052049500111
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2025
• Report Date (Section F): 08/13/2025

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 TIGHT 1.2
• Device Catalogue Number: GA-5200000US
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2025
• 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: 08/13/2025