BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLIEF BASIC GENERATOR

    MDR report key: 23206657 · Received October 2, 2025

    Report

    Report Number
    3011270181-2025-00034
    Event Type
    Injury
    Date Received
    October 2, 2025
    Report Date
    May 15, 2026
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    GXD
    UDI-DI
    00193949347302
    PMA / PMN Number
    K192491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6 HEALTH EFFECT - CLINICAL CODE/APPROPRIATE TERM / CODE NOT AVAILABLE: NEURITIS. THE SAMPLE IS REPORTEDLY AVAILABLE FOR THIS COMPLAINT BUT WAS NOT RETURNED WHEN THIS REPORT WAS FILED THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI NUMBER ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 02-OCT-2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP-(B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2025-00033 FOR THE FIRST EVENT. REFER TO 3011270181-2025-00035 FOR THE THIRD EVENT. IT WAS REPORTED THE PATIENT IS EXPERIENCING NEURITIS SYMPTOMS WITH STANDARD RADIOFREQUENCY THERAPY. THE PROVIDER IS USING THE CORRECT LENGTH AND CURVE SUPPLIED. THE PATIENT WAS TREATED WITH STEROID PACK. ADDITIONAL INFORMATION RECEIVED 09-SEP-2025 NOTED THE RADIOFREQUENCY THERAPY GENERATOR SETTINGS ARE 80 DEGREES FOR TEMPERATURE, 15-SECONDS RAMP AND 2-MINUTES LESION TIME. NO ERROR WAS DISPLAYED ON THE RADIOFREQUENCY THERAPY GENERATOR, BUT THE PATIENT WAS HAVING ISSUES NEURITIS PLUS PAIN WHICH WAS NOT RESOLVED BY THE STEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146936 COOLIEF BASIC GENERATOR CRG - COOLIEF RADIOFREQUENCY GENERATOR GXD AVANOS MEDICAL INC. CRG-BASIC STZ25015-013 00193949347302

    Patients

    Seq Age Sex Outcome Treatment
    1