BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RF PROBE

    MDR report key: 9269441 · Received November 1, 2019

    Report

    Report Number
    8030647-2019-00096
    Event Type
    Injury
    Date Received
    November 1, 2019
    Report Date
    November 1, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    GXI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 29-OCT-2019 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 (B)(4). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED CLINICAL ARTICLE FROM THE WEBSITE, WWW.PAINREPORTS.COM ENTITLED "A RARE COMPLICATION OF HEMATOMA AFTER GENICULAR NERVE RADIOFREQUENCY ABLATION." AUTHORS: NATHALIE STRAND, PAOLA JORGE, JOHN FREEMAN, AND RYAN D'SOUZA, DATED 11-DEC-2018 NOTED THE FOLLOWING: CASE PRESENTATION: A (B)(6)-YEAR-OLD MAN WITH A HISTORY OF SEVERE BILATERAL KNEE OSTEOARTHRITIS AND GRADE 4 CHONDROMALACIA PRESENTED TO OUR CLINIC WITH REFRACTORY, SEVERE BILATERAL KNEE PAIN AND RECEIVED A BILATERAL GENICULAR NERVE RFA. HE RETURNED 4 DAYS LATER WITH RIGHT MEDIAL THIGH PAIN AND A MAGNETIC RESONANCE IMAGING STUDY REVEALING A HEMATOMA ALONG THE ANTEROMEDIAL ASPECT OF THE RIGHT DISTAL FEMORAL DIAPHYSIS MEASURING 13.3X4.5X3.0 CM. AFTER COLLABORATION BETWEEN PAIN MEDICINE AND ORTHOPEDIC SURGERY SERVICES, DECISION WAS MADE TO TREAT PATIENT CONSERVATIVELY WITH REST, COMPRESSION, ELEVATION, ICE APPLICATION, TRAMADOL, AND GABAPENTIN, BUT WITH CLOSE FOLLOW-UP AND A LOW THRESHOLD TO INTERVENE WITH DIAGNOSTIC AND THERAPEUTIC ANGIOGRAPHY WITH EMBOLIZATION IF BLEEDING WORSENED; HE REPORTED RESOLUTION OF HIS PAIN AFTER A 4-DAY AND 1-MONTH FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062131 UNKNOWN RF PROBE COOLED RF PROBES AND CANNULAS GXI AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention