BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIRA INNOVATIONS INC.

    MDR report key: 23922870 · Received December 30, 2025

    Report

    Report Number
    3015109022-2025-00002
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    August 5, 2025
    Report Date
    November 6, 2025
    Manufacturer
    NIRA INNOVATIONS INC.
    Product Code
    OHS
    UDI-DI
    00850020752454
    PMA / PMN Number
    K222685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 06 AUGUST 2025, NIRA INNOVATIONS INC. RECEIVED INITIAL INFORMATION FROM A CONSUMER REPORTING LOCALIZED FACIAL BURNS AND BLISTER FORMATION FOLLOWING USE OF THE NIRA PRO+ LASER. THE CONSUMER WAS CONTACTED FOR FOLLOW-UP, ADVISED TO DISCONTINUE USE, AND REQUESTED TO RETURN THE DEVICE FOR EVALUATION. THE CONSUMER REMAINED IN COMMUNICATION WITH THE MANUFACTURER THROUGH THE INVESTIGATION PERIOD AND WAS CONTACTED PERIODICALLY FOR STATUS UPDATES. ON (B)(6) 2025, DURING FOLLOW-UP CORRESPONDENCE, THE CONSUMER REPORTED THAT THE AFFECTED AREA HAD HEALED WITH A RESIDUAL SCAR AND THAT A DERMATOLOGIST HAD RECOMMENDED RESURFACING TREATMENT. AT THAT TIME, THE MANUFACTURER DETERMINED THAT THE CASE MET THE DEFINITION OF A SERIOUS INJURY (PERMANENT IMPAIRMENT) UNDER 21 CFR 803.3. THE RETURNED DEVICE UNDERWENT A INVESTIGATION TO VERIFY LASER OUTPUT. THE LASER OUTPUT WAS FOUND TO BE WITHIN THE SPECIFICATION. FOLLOWING CONFIRMATION OF THE PERSISTENT SCAR AND MEDICAL CONSULTATION, THE EVENT WAS CLASSIFIED AS A SERIOUS INJURY, AND THIS MEDICAL DEVICE REPORT WAS SUBMITTED TO THE U.S. FDA WITHIN THE REQUIRED 30-DAY REPORTING PERIOD.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A CONSUMER REPORTED SUSTAINING A FACIAL BURN AFTER USING THE NIRA PRO+ LASER. THE DEVICE WAS APPLIED TO THE LOWER CHEEK ON DRY, CLEAN SKIN. SHORTLY AFTER USE, THE CONSUMER NOTICED REDNESS AND A BURNING SENSATION, WHICH PROGRESSED TO BLISTER FORMATION WITHIN HOURS. THE CONSUMER DISCONTINUED FURTHER USE IMMEDIATELY AND SELF-TREATED WITH TOPICAL NEOSPORIN. FOLLOW-UP COMMUNICATION CONFIRMED A LOCALIZED BURN WITH BLISTER FORMATION ON THE LOWER CHEEK. SHE WAS ADVISED TO DISCONTINUE USE AND TO CONSULT A HEALTHCARE PROVIDER OR DERMATOLOGIST. THE DEVICE WAS RETURNED ON 04 SEP 2025 FOR EVALUATION UNDER THE COMPANY'S REFUND AND INVESTIGATION PROCESS, AND NIRA RECEIVED IT ON (B)(6) 2025. DURING FOLLOW-UP, THE CONSUMER REPORTED THAT THE AREA WAS HEALING BUT REMAINED DISCOLORED. ON (B)(6) 2025, DURING A FOLLOW-UP CALL, SHE REPORTED RESIDUAL SCARRING ON THE AFFECTED SITE AND PROVIDED A NOTE FROM HER DERMATOLOGIST RECOMMENDING RESURFACING TREATMENT. BECAUSE THE BURN RESULTED IN PERSISTENT SCARRING AND REQUIRED MEDICAL CONSULTATION, THE MANUFACTURER CLASSIFIED THIS EVENT AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887438 NIRA INNOVATIONS INC. NIRA PRO+ OHS NIRA INNOVATIONS INC. 160-001 060220251 00850020752454

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention