BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGUSEAL MICROBIAL SKIN SEALANT 200IN 4

    MDR report key: 4838976 · Received June 11, 2015

    Report

    Report Number
    3011270181-2015-00001
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Report Date
    June 25, 2015
    Manufacturer
    HALYARD HEALTH
    Product Code
    NZP
    PMA / PMN Number
    PK052870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE RETURNED. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. 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

    A REPORT WAS RECEIVED ALLEGING THAT OVER THE PAST YEAR THERE HAVE BEEN AN INCREASE IN THE NUMBER OF CHEST INFECTIONS. NO SPECIFICS ON THE INFECTIONS WERE PROVIDED NOR THE NUMBER OF OCCURRENCES. THE TIMING OF THE INCREASE CORRESPONDS WITH INTRODUCTION ON THE MICROBIAL SKIN SEALANT PRODUCT INTO OPERATING ROOM. THE HEALTHCARE PROFESSIONALS AT THE FACILITY CHANGED THEIR CLINICAL PRACTICES. ONE OF THESE CHANGES WAS TO ELIMINATE THE USE OF THE MICROBIAL SKIN SEALANT PRODUCT. THEY CLAIM THAT SINCE THE CHANGE IN PRACTICE, THE NUMBER OF INFECTIONS HAS DECREASED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382288 INTEGUSEAL MICROBIAL SKIN SEALANT 200IN 4 MICROBIAL SEALANT (INTEGUSEAL) NZP HALYARD HEALTH 33737 P00202365

    Patients

    Seq Age Sex Outcome Treatment
    1