BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKOWN ON-Q PAIN PUMP

    MDR report key: 8333992 · Received February 12, 2019

    Report

    Report Number
    2026095-2019-00026
    Event Type
    Injury
    Date Received
    February 12, 2019
    Report Date
    January 17, 2019
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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 12-FEB-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).

    Description of Event or Problem · 1

    IT WAS REPORTED, "I HAD THIS INSERTED BEFORE HAVING A PLATE AND 9 PINS PLACED IN MY CALCANEUS AND REMOVED IT AT HOME AS INSTRUCTED BY MY PHYSICIAN. I HAD NOTHING BUT ISSUES, INCLUDING 2 ADDITIONAL SURGERIES AND A STAY IN ICU., AFTER USING THIS PRODUCT. IT MAY HAVE ASSISTED WITH PAIN AT THE TIME BUT HAS CAUSED LIFE LONG NERVE DAMAGE TO MY LEGS. BEWARE AND ASK A LOT OF QUESTIONS BEFORE AGREEING TO THIS ALTERNATIVE RX".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125202 UNKOWN ON-Q PAIN PUMP UNKNOWN ELASTOMERIC PUMP MEB AVANOS MEDICAL - IRVINE UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other