BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOBAR

    MDR report key: 3625093 · Received February 3, 2014

    Report

    Report Number
    2025917-2014-00004
    Event Type
    Injury
    Date Received
    February 3, 2014
    Date of Event
    January 1, 2002
    Report Date
    January 6, 2014
    Manufacturer
    NEOTECH PRODUCTS, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT COULD NOT PROVIDE THIS INFO. A DEVICE EVAL WAS NOT PERFORMED, AS NO DEVICE WAS RETURNED TO THE MFR AND NO LOT NUMBER WAS PROVIDED. ALSO, WE ARE UNAWARE OF ANY PREVIOUS COMPLAINTS OF THIS NATURE FROM THE FACILITY, BUT HAVE ASKED THAT THE USER FACILITY CONTINUE TO MONITOR THESE EVENTS AND INFORM NEOTECH IMMEDIATELY SHOULD ANY FURTHER INCIDENTS OCCUR. THE USER FACILITY STAFF BELIEVES THAT THE ISSUE "MAY BE DUE TO THE MATURITY OF THE PATIENT'S SKIN, OR POSSIBLY THE THICKNESS OF THE ADHESIVE PADS ON THE LARGER BAR. THE PEACH BAR IS USED ON LARGER, OLDER GESTATION PATIENTS." AS NO LOT NUMBER WAS PROVIDED, WE WERE UNABLE TO DETERMINE A MFR DATE. NEOTECH WILL CONTINUE TO MONITOR THE SITUATION AND WILL SUBMIT A SUPPLEMENTAL REPORT SHOULD ANY FURTHER PERTINENT INFO BECOME AVAILABLE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PEACH-COLORED ET TUBE HOLDERS DO NOT SEEM "TO STICK AS WELL TO THE PATIENT AS THE OTHER SIZES." THE COMPLAINANT RECEIVED THIS INFO FROM A MEMBER OF HIS STAFF, WHO STATED THAT THERE HAD BEEN SOME "ACCIDENTAL EXTUBATIONS AND SEVERAL HAVE BEEN WITH THE PEACH BAR, BUT THESE PATIENTS HAVE ALSO BEEN SURGERY PATIENTS WAKING UP FROM ANESTHESIA AND BECOMING MORE RESTLESS." THE STAFF MEMBER COULD NOT GIVE A SPECIFIC NUMBER OF INCIDENTS OR ANY SPECIFIC DATES AND STATED, "MY CONCERN IS REALLY JUST AN OBSERVATION OF ALL THE YEARS (ALMOST 12 YEARS NOW) I HAVE USED YOUR PRODUCT, WHICH I REALLY LIKE USING." SHE COULD OFFER NO MORE SPECIFIC DETAILS REGARDING ANY OF THE EVENTS AND STATED, "IN ORDER TO ANSWER THOSE VERY SPECIFIC QUESTIONS, I WILL HAVE TO WAIT UNTIL WE HAVE ANOTHER PATIENT(S) USING THE PEACH BAR AND NOTE ALL THOSE THINGS." SHE CONFIRMED THAT SHE BELIEVED THAT THE STAFF WAS PROPERLY FOLLOWING THE DIRECTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71309 NEOBAR ET TUBE HOLDER CBH NEOTECH PRODUCTS, INC. N715F

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention