BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLIEF COOLED RF ADVANCED-R GENERATOR

    MDR report key: 11504093 · Received March 17, 2021

    Report

    Report Number
    3011270181-2021-00015
    Event Type
    Injury
    Date Received
    March 17, 2021
    Date of Event
    March 4, 2021
    Report Date
    March 17, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    GXD
    UDI-DI
    00193493473038
    PMA / PMN Number
    K192491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, EACH UNIT MUST MEET 100% OF PERFORMANCE, TESTED FOR SAFETY, PERFORMANCE, AND FUNCTION PRIOR TO DISTRIBUTION. ALL INFORMATION REASONABLY KNOWN AS OF 16 MAR 2021 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 COMPLAINT DATABASE AND IDENTIFIED AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COOLIEF PROCEDURE WAS PERFORMED ON A PATIENT, WHERE TWO LESIONS WERE CREATED FOR THE TREATMENT OF HIP PAIN. DURING THE PROCEDURE, THE PATIENT WAS "UNCOMFORTABLE AND SWEATING SOMEWHAT." A FEW DAYS LATER, THE PATIENT STARTED EXPERIENCING PAIN, NUMBNESS, AND WEAKNESS IN THE RIGHT LEG, AND A TEMPERATURE OF 99 DEGREES FAHRENHEIT. THE PATIENT VISITED A PHYSICIAN WHO "PRESCRIBED MEDICATIONS." AFTER A FEW WEEKS THE PAIN HAD NOT RESOLVED, SO THE PATIENT VISITED THE EMERGENCY ROOM AND RECEIVED A MRI. "THE MRI RESULT SHOWED OSTEOMYELITIS AT THE FEMORAL JOINT. PATIENT THEN HAD SURGERY FOR DEBRIDEMENT OF THE AFFECTED JOINT. DURING SURGERY THERE WERE NO VISIBLE SIGNS OF DRAINAGE OR INFECTION. A CULTURE WAS TAKEN FOR LABS AND SHOWED SKIN STAPHYLOCOCCUS. THE PATIENT WAS THEN PRESCRIBED ANTIBIOTICS FOR 6 WEEKS. PREVIOUS TO THE COOLIEF PROCEDURE THE PATIENT HAD AN INTERARTICULAR STEROID INJECTION TO THE JOINT OF THE AFFECTED HIP. HIS HIP PAIN HAD INCREASED PRIOR TO THE COOLIEF PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401898 COOLIEF COOLED RF ADVANCED-R GENERATOR CRG - COOLIEF RADIOFREQUENCY GENERATOR GXD AVANOS MEDICAL INC. CRG-ADVANCED-R STZ20114-005 00193493473038

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention