BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MIC-KEY

    MDR report key: 7310747 · Received March 2, 2018

    Report

    Report Number
    9611594-2018-00018
    Event Type
    Injury
    Date Received
    March 2, 2018
    Report Date
    February 12, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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 27-FEB-2018 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 HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF 13-MAR-2018 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 HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED REDNESS, INFLAMMATION, AND A SLIGHTLY PURULENT DISCHARGE AT THE STOMA SITE ASSOCIATED WITH THE USE OF A MIC-KEY DEVICE. THE PATIENT WAS TREATED WITH BISEPTINE. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT'S HUSBAND MANIPULATED THE PUMP BY REDUCING THE CONTINUOUS FLOW FROM 5.6 ML/H TO 3.3 ML/H THROUGH THE GUIDANCE OF THE NEUROLOGIST BECAUSE OF SIGNIFICANT COGNITIVE IMPAIRMENT. THE PATIENT ALSO EXPERIENCED FREQUENT BACK AND KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153392 UNKNOWN MIC-KEY UNKNOWN MIC-KEY KNT HALYARD HEALTH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other