BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ELASTOMERIC LFR

    MDR report key: 9808838 · Received March 9, 2020

    Report

    Report Number
    2026095-2020-00039
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Report Date
    March 9, 2020
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 09 MAR 2020 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).

    Description of Event or Problem · 1

    FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: TOTAL KNEE REPLACEMENT, CATHPLACE: ADDUCTOR CANAL BLOCK, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. FDA MEDWATCH / FDA USER FACILITY REPORT # MW 5092810 RECEIVED ON (B)(6) 2020, AND THE FOLLOWING INFORMATION WAS PROVIDED: "AN (DATE REDACTED) Y/O FEMALE WHO UNDERWENT A TOTAL KNEE REPLACEMENT HAS AN ADDUCTOR CANAL BLOCK AND CATHETER PLACED FOR POST-OP ANALGESIA. SHE WAS DISCHARGED HOME WITH THE CATHETER IN PLACE AND ATTACHED TO AN ONQ PAIN PUMP (AVANOS MEDICAL) IN THE MIDDLE OF THE NIGHT AROUND MIDNIGHT WE WOKE FROM SLEEP AND HER ENTIRE SURGICAL LEG WAS NUMB WITH LOSS OF PROPRIOCEPTION AND MOTOR FUNCTION. NO SYSTEMIC TOXICITY SYMPTOMS AT THAT TIME SHE STOPPED THE PUMP AND A RELATIVE CLAMPED IT WITH A PAPER CLIP. SHE WAS INSTRUCTED TO REMOVE THE CATHETER AND A FEW HOURS AFTER DOING SO THE SENSATION RETURNED T THAT LEG NO MORE SEQUELAE OCCURRED THE DEVICE WAS SHIPPED BACK TO US AT THE HOSPITAL THE BALL OF ROPIVACAINE 0.2% APPEARS TO BE TOTALLY EMPTY WE ARE CONCERNED THAT THE DEVICE MALFUNCTIONED AND WOULD LIKE IT TO BE EXAMINED BY YOU FOR THIS ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268142 UNKNOWN ELASTOMERIC LFR ELASTOMERIC LFR MEB AVANOS MEDICAL - IRVINE UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1