BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUERA

    MDR report key: 24504180 · Received March 4, 2026

    Report

    Report Number
    1720381-2026-00002
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    January 20, 2026
    Report Date
    March 4, 2026
    Manufacturer
    BIOS S.R.L.
    Product Code
    PBX
    PMA / PMN Number
    K151296
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, PATIENT PHOTO. THE CUSTOMER REPORTED: "DURING TREATMENT, THE AREA WHERE THE GROUNDING PAD IS PLACED GOT HOT AND CREATED WELTS/BLISTERS IN THE AREA. NO DAMAGE TO THE PAD BUT EVERYWHERE THEY PLACE IT, IT GETS HOT. USING RF CREAM (DESIGNED FOR RF DEVICES FROM KOREA). THIS HAPPENED YESTERDAY BUT TODAY THERE'S NO ISSUE. NEVER EXPERIENCED IT BEFORE. PROVIDER EXPERIENCE SHOCK AS WELL." THE REGIONAL CLINICAL EXPERT HAS REVIEWED THE AVAILABLE INFORMATION AND ADVISED AS FOLLOWS: 5 - MINOR INJURY REQUIRING NON-SURGICAL TREATMENT. "BIOS AND THE IMPORTER RECEIVED A REPORT OF AN ADVERSE EVENT INVOLVING THE NU ERA DEVICE. THE PATIENT IS A FEMALE (B)(6). PER THE REPORT, 6 MINS INTO TREATMENT THE GROUNDING PAD GOT HOT AND THE PATIENT COMPLAINED. THE GROUNDING PAD WAS MOVED AND TREATMENT ATTEMPTED AGAIN, WITH THE SAME HEAT FELT. ANOTHER STAFF MEMBER ASSISTED BY PLACING HER HAND ON THE GROUNDING PAD TO SECURE IT AND FELT A SHOCK (WITH NO INJURY). POST TREATMENT THE PATIENT WAS NOTED TO HAVE ERYTHEMA, WELTS, AND BLISTERING. SETTINGS ARE RECORDED AS 80MM ELECTRODE MONOPOLAR TO A SKIN TEMPERATURE OF 43C. THE FREQUENCY WAS NOT LISTED. THE REPORT STATES ALL JEWELRY WAS REMOVED FROM ALL PARTIES PRIOR TO TREATMENT. ROOT CAUSE: FAILURE IS NOT IDENTIFIED." BIOS REVIEWED RECEIVED DATA AND ADVISED AS FOLLOWS: "1. IN THIS SPECIFIC CASE, IT IS EXTREMELY UNLIKELY THAT THE CREAM USED CONTRIBUTED TO THE REPORTED ISSUE (PARTLY BECAUSE THIS CREAM HAS ALREADY BEEN EXTENSIVELY TESTED BY THE USER, AND PARTLY BECAUSE THE PROBLEM OCCURRED ON THE RETURN PLATE). "2. THE FACT THAT THE PLATE WAS USED 888 TIMES SAYS EVERYTHING AND NOTHING: PLATE WEAR DOES NOT DEPEND ON THE NUMBER OF USES, BUT RATHER ON HOW IT IS USED AND CLEANED. IN PARTICULAR, AGGRESSIVE CLEANING OR THE USE OF HARSH SUBSTANCES CAN THIN THE CONDUCTIVE RUBBER LAYERS, WHILE REPEATED BENDING OF THE PLATE AND CABLE CAN CAUSE INTERNAL BREAKAGE OF THE WIRE OR OF THE CONDUCTIVE MESH EMBEDDED IN THE RUBBER. HYPOTHESES: A. THE PATIENT'S SKIN WAS IN A STATE OF SEVERE DEHYDRATION, SIGNIFICANTLY INCREASING SURFACE RESISTIVITY AND CAUSING EXCESSIVE OVERHEATING (IN PARTICULAR, IF THE IRRITATION IS EXTENSIVE AND FOLLOWS THE SHAPE AND DIMENSIONS OF THE PLATE AND/OR ABNORMAL OVERHEATING OCCURRED ACROSS THE ENTIRE SURFACE OF THE PLATE, THIS IS THE ONLY POSSIBLE EXPLANATION). B. OTHER EXTERNAL FACTORS INCREASED THE SKIN'S SURFACE RESISTIVITY (FOR EXAMPLE, PRESENCE OF FOUNDATION, OIL, OR OTHER COSMETIC PRODUCTS). C. THE PLATE WAS NOT KEPT IN SUFFICIENT CONTACT WITH THE SKIN (THIS IS A VERY COMMON OCCURRENCE, ALTHOUGH LESS LIKELY IF THE DOCTOR ATTEMPTED TO REPOSITION THE PLATE IN VARIOUS LOCATIONS). D. THE INTERNAL CONDUCTOR WITHIN THE CABLE OR THE CONDUCTIVE MESH INSIDE THE PLATE BROKE DUE TO REPEATED BENDING (IN THIS CASE, THE PROBLEM SHOULD REAPPEAR INTERMITTENTLY, ALWAYS IN THE SAME AREA OF THE PLATE). IN THE PHOTOS (HERE ATTACHED) OF THE PLATE, THE CABLE APPEARS SLIGHTLY WORN, AND ONE AREA OF THE PLATE LOOKS SLIGHTLY SWOLLEN (IT COULD CONCEAL AN IMPERFECT INTERNAL CONTACT THAT OVERHEATED)." SINCE THE INJURY IS MINOR (RATED 5). DUE TO LACK OF THE INFORMATION FROM THE CUSTOMER, WE'LL CONCLUDE THAT, THE ROOT CAUSE OF THE INJURY WAS NOT ESTABLISHED. AT THE SAME TIME, WE DIDN'T RECEIVE PROVEN EVIDENCE OF ANY FAILURE OF THE DEVICE AND THEREFORE CANNOT CONFIRM ANY INJURY-RELATED DEVICE MALFUNCTION AND 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

    Description of Event or Problem · 0

    BIOS REVEIVED FROM LUMENIS (THE IMPORTER) THE NOTIFICATION ON AN ADVERSE EVENT EPORTS THAT DURING TREATMENT, THE AREA WHERE THE GROUNDING PAD IS PLACED GOT HOT AND CREATED WELTS/BLISTERS IN THE AREA. NO DAMAGE TO THE PAD BUT EVERYWHERE THEY PLACE IT, IT GETS HOT. USING RF CREAM (DESIGNED FOR RF DEVICES FROM KOREA). THIS HAPPENED YESTERDAY BUT TODAY THERE'S NO ISSUE. NEVER EXPERIENCED IT BEFORE. PROVIDER EXPERIENCE SHOCK AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572172 NUERA RADIOFREQUENCY SYSTEM PBX BIOS S.R.L. NUERA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female