BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PMG-ADVANCED V4.2A

    MDR report key: 19037430 · Received April 3, 2024

    Report

    Report Number
    3011270181-2024-00043
    Event Type
    Injury
    Date Received
    April 3, 2024
    Report Date
    August 20, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    GEI
    UDI-DI
    10680651422979
    PMA / PMN Number
    K163461
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D1 ALL INFORMATION REASONABLY KNOWN AS OF 07-JUN-2024 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). 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

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 03-APR-2024 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). 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. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, ST8003-008, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2024 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). 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

    IT WAS REPORTED THE "MACHINE WAS NOT ABLE TO ACHIEVE BURNING TEMPERATURE, WITH IMPEDANCE RISING FROM 500 TO 2200 OHMS PRIOR TO SELF-TERMINATING AFTER APPROXIMATELY 40 SEC ATTEMPTED FURTHER 2 ATTEMPTS AT RF AT ABOVE SETTINGS WITH SAME ISSUE PULLED BACK BLANKET TO ENSURE DIATHERMY PAD WAS WELL ADHERED TO THE LEG IN CASE THAT WAS THE ISSUE AND NOTED CHARRING. IMMEDIATELY TURNED OFF THE MACHINE AND INSTRUCTED [THE PHYSICIAN] TO TERMINATE THE PROCEDURE." THE PATIENT'S INJURIES NOTED TWO POINTS OF BURN ON THE CORRESPONDING TO DIAGONAL POINTS OF THE DIATHERMY PAD - TWO BURNS ON THIGH WITH CHARRING. "UNCLEAR IF ARCED OVER SKIN OR THROUGH MUSCLE. MEDICAL TREATMENT WAS PROVIDED SECONDARY TO BURNS TO THIGHS. THE CLINICIANS "IMPRESSION IS THAT THERE WAS POOR CONTACT OF THE SKIN ADHESIVE TO THE SKIN DUE TO INTERFERENCE FROM HAIR." MEDICAL TREATMENT "WAS PROVIDED SECONDARY TO BURNS TO THIGHS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729643 PMG-ADVANCED V4.2A PAIN MANAGEMENT GENERATORS & ACCESSORIES GEI AVANOS MEDICAL INC. PMG-ADVANCED ST8003-008 10680651422979

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention