BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGUSEAL MICROBIAL SKIN SEALANT 200IN 4

    MDR report key: 5022743 · Received August 21, 2015

    Report

    Report Number
    3011270181-2015-00017
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Report Date
    July 24, 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

    (B)(4). THE SAMPLES WERE RECEIVED WITH THE PLUNGER FULLY DEPRESSED. THERE WAS NO EVIDENCE OF CYANOACRYLATE DISPENSING ON THE SPONGE APPLICATOR OR ON THE EXTERIOR OF THE HOUSING. THE SIDE WELDS WERE INTACT WITH NO BULGING. 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).

    Description of Event or Problem · 1

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT REPORTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3011270181-2015-00016 FOR THE FIRST REPORT. 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. IT WAS REPORTED THAT THERE HAVE BEEN TIMES WHERE THE INTEGUSEAL DID NOT DEPLOY ANY LIQUID. EXACT DATE/NUMBER OF OCCURRENCES WAS UNKNOWN. THE DEVICES WERE NOT RETAINED FOR EVALUATION. THE HEALTHCARE PROFESSIONALS AT THE FACILITY CHANGED THEIR CLINICAL PRACTICES. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555318 INTEGUSEAL MICROBIAL SKIN SEALANT 200IN 4 MICROBIAL SEALANT NZP HALYARD HEALTH 33737 P00202365

    Patients

    Seq Age Sex Outcome Treatment
    1