BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ELASTOMERIC PUMP

    MDR report key: 9314959 · Received November 13, 2019

    Report

    Report Number
    2026095-2019-00182
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    January 24, 2019
    Report Date
    November 13, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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-NOV-2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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

    AN FDA MEDWATCH / FDA USER FACILITY REPORT # MW 5090053 WAS RECEIVED. THE FOLLOWING INFORMATION WAS PROVIDED: I HAD NEUROLYSIS SURGERY WITH AN ON-Q PAIN PUMP WITH LEFT IN MY SURGICAL SITE ON (DATE REDACTED) I HAD SEVERE BURNING AND HORRIBLE PAIN ABOVE THE SURGICAL SITE BUT BELOW THE ENTRANCE OF THE CATHETER THE PAIN WAS SO SEVERE I WENT T THE HOSP I RECEIVED A BURN MULTIPLE LAYERS THICK WITH SCARRING AND NOW HAVE NO SENSATION IN MY SKIN IN THAT AREA AND THE NERVE THAT WAS OPERATED ON GENERALLY HAS NO TO LITTLE FUNCTION I AM SIGNIFICANTLY DISABLED AND FEEL THE PUMP FAILED AND DISPENSED TOO MUCH PAIN MEDICINE I HAVE NOT WORKED DUE TO THIS AND NOW REQUIRE ASSISTIVE DEVICES TO WALK THE ON-Q PUMP IS A DANGEROUS DEVICE IT EVIDENTLY CAN EXPRESS TOO MUCH MEDICATION BY COMPRESSING THE PUMP THE KIND OF PUMP I HAD DID NOT HAVE ANY CONTROL ON IT TO ADJUST THE FLOW AND CAN PUT OUT TOO MUCH MED JUST BY ROLLING OVER ON THE BALL OF MEDICATION PRE-OPERATIVE NERVE FUNCTION WAS BETTER THAN POSTOPERATIVE WITH SIGNIFICANT LOSS OF NERVE FUNCTION SURGERY WAS ON (DATE REDACTED) 2019, BUT SEVERE PAIN WAS ON (DATE REDACTED) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111000 UNKNOWN ELASTOMERIC PUMP ELASTOMERIC LFR MEB AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other