BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ON-Q ELASTOMERIC PUMP

    MDR report key: 11590374 · Received March 30, 2021

    Report

    Report Number
    2026095-2021-00047
    Event Type
    Injury
    Date Received
    March 30, 2021
    Report Date
    March 30, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2021-00048 FOR THE SECOND REPORT. REFER TO 2026095-2021-00049 FOR THE THIRD REPORT . FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: ACHILLES TENDON SURGERY, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THE PATIENT HAD ACHILLES TENDON SURGERY SIX MONTHS AGO AND HAS BEEN EXPERIENCING "NUMBNESS AND TINGLING SENSATION THAT STARTS IN THE BALL OF THE FOOT UP THROUGH THE TOES" EVER SINCE THE SURGERY. PATIENT STATED THE DEVICE WORKED WELL FOR PAIN MANAGEMENT AND IS DOING VERY WELL AND FEELS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487926 UNKNOWN ON-Q ELASTOMERIC PUMP ELASTOMERIC HFR MEB AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other