BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTAT

    MDR report key: 2817658 · Received October 25, 2012

    Report

    Report Number
    2817658
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 25, 2012
    Manufacturer
    KNY SCHEERER
    Product Code
    HRQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE REMOVAL OF A POWER PORT, THE HEMOSTAT THAT WAS CLAMPING THE PATIENT'S PORT BROKE. THE NURSE SPECIALIST SUCCESSFULLY LOCATED AND REMOVED THE BROKEN PIECE OF THE HEMOSTAT FROM THE PATIENT'S BODY. THE PATIENT WAS NOT INJURED. UP UNTIL FOUR YEARS AGO, THE HEMOSTATS WERE ETCHED WITH THE DATE OF PURCHASE AND THIS PARTICULAR HEMOSTAT HAS AN ETCHED DATE, BUT ETCHING IS NOT LEGIBLE. THE HEMOSTAT WAS INSPECTED VISUALLY BEFORE PACKAGING INTO THE PROCEDURE KIT, BUT THE FRACTURED JAW WOULD NOT BE VISIBLE WITH THIS TYPE OF INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSTAT HEMOSTAT, SURGICAL HRQ KNY SCHEERER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR