BEUDAMED
    FDA Adverse Event Death Summary report: N

    24-HOUR ORAL CARE KIT WITH BALLARD* TECHNOLOGY, Q4 WITH CHG

    MDR report key: 7560846 · Received June 1, 2018

    Report

    Report Number
    3006646024-2018-00021
    Event Type
    Death
    Date Received
    June 1, 2018
    Report Date
    May 10, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    JOL
    UDI-DI
    30680651139031
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CODE: NO CODE (TONGUE SWELLING). 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 31-MAY-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 COMPLAINT (B)(4). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 3006646024-2018-00019 FOR THE FIRST EVENT. REFER TO 3006646024-2018-00020 FOR THE SECOND EVENT. REFER TO 3006646024-2018-00022 FOR THE FOURTH EVENT. THE PATIENT EXPERIENCED TONGUE SWELLING AFTER USING THE ORAL CARE KIT. THE PATIENT DIED DUE HEALTH ISSUES. THE CLINICIANS REPORTED THE SWELLING COMPLICATION WERE UNCOMFORTABLE SYMPTOMS WHICH DID NOT MAKE THE PATIENT'S CONDITION BETTER, BUT THE PATIENT'S UNDERLYING AGE, AND COMORBIDITIES HAD MORE TO DO WITH THE PATIENT'S PASSING RATHER THAN THE TONGUE SWELLING. THE KITS WERE ONLY IDENTIFIED FOR COMMON TREATMENT ACROSS ALL THE AFFECTED PATIENTS IN WHICH THE SYMPTOMS WERE ATTRIBUTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405053 24-HOUR ORAL CARE KIT WITH BALLARD* TECHNOLOGY, Q4 WITH CHG VAP ORAL CARE PRODUCTS JOL HALYARD HEALTH 97014 30680651139031

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Death