MAUDE Adverse Event Report: BIOS S.R.L. NUERA TIGHT; RADIOFREQUENCY 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
Bios and the importer 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 august 20, 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 bios 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.
Event or Problem Description
Bios received from lumenis (the importer) the notification on 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 felt hot during the treatment.

• Brand Name: NUERA TIGHT
• Common Device Name: RADIOFREQUENCY SYSTEM
• Manufacturer (Section D): BIOS S.R.L.; via guido rossa, 10/12; vimodrone (mi), italy 20055 ; IT 20055
• Manufacturer (Section G): BIOS S.R.L.; via guido rossa, 10/12; vimodrone (mi), italy 20055 ; IT 20055
• Manufacturer Contact: edoardo tronchet ; via guido rossa, 10/12; vimodrone (mi), italy 20055 ; IT 20055
• MDR Report Key: 22892963
• Report Number: 1720381-2025-00004
• Device Sequence Number: 12974730
• Product Code: PBX
• UDI-Device Identifier: 08052049500111
• UDI-Public: 08052049500111
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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 Lot Number: SN. NT1451-20M-111
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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