MAUDE Adverse Event Report: LUTRONIC CORPORATION XERF

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A member of the cynosure lutronic clinical team made contact with the treatment provider who reported that the patient reported a warm sensation under the nem pad, however, it was tolerable and did not interrupt the treatment session.The blistering was observed near the applied disposable patch and became visible near the end of the treatment session.The clinical details were requested on multiple occasions, despite these requests, the treatment provider did not disclose any information to the clinical team.The operators manual (om) states that that "patient return pad must be thoroughly adhered to the proper area of the patient's body as specified by the manufacturer.Avoid bony-prominences and hair when adhering the patient return pad to the patient to decrease the risk of adverse effects or burns.Patient return pad cables should be positioned in such a way that they do not come into contact with the patient or other cables." images of the patient burns were provided on 1/14/2026 and were forwarded to the cynosure lutronic medical director for review and expert clinical assessment.At this time based on the images provided a full thickness burn with possible burning was diagnosed.Based on the information that was provided, it was determined that the cause of this event is consistent with user error.The treatment provider confirmed that the grounding pad was applied to the upper back, which is a curved and bony area.As a result, it is likely that the grounding pad did not remain in full contact with the patient skin.This is further supported by the patient reporting a warm sensation at the pad site during treatment.To reduce the probability or reoccurrence, the potential side effects were discussed in detail with the treatment provider.Additionally, alternative grounding pad placement options were reviewed in accordance with the recommendations outlined in the om.Since a reported a serious injury occurred, we are reporting this event.
Event or Problem Description
It was reported that following monopolar radiofrequency treatment on the face with a xerf device, the treatment provider observed a blister on the upper lateral side of the nem pad area.

• Brand Name: XERF
• Common Device Name: XERF
• Manufacturer (Section D): LUTRONIC CORPORATION; lutronic center; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• Manufacturer (Section G): LUTRONIC CORPORATION; lutronic center; 219, sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• Manufacturer Contact: nirav desai ; 5 carlisle rd; westford, MA 01886
• MDR Report Key: 24146038
• Report Number: 3021199089-2026-00003
• Device Sequence Number: 8859785
• Product Code: GEX
• UDI-Device Identifier: 08809447657981
• UDI-Public: 08809447657981
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female