BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BANYAN STAT KIT

    MDR report key: 3775726 · Received April 22, 2014

    Report

    Report Number
    MW5035785
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    February 18, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BANYAN INTERNATIONAL CORP.
    Product Code
    LRR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I ORDERED AN EMERGENCY MEDICATION KIT FROM (B)(6). IT WAS SHIPPED TO MY OFFICE MISSING 7 MEDICATIONS. I WAS NOT NOTIFIED OF THE MISSING ITEMS. WHEN I RECEIVED THE KIT I DISCOVERED IT WAS INCOMPLETE. AS OF TODAY (B)(6) 2013 I AM STILL MISSING 1 MED, 14 MONTHS LATER. I WOULD NOT HAVE ORDERED THIS KIT IF INFORMED IT WAS MISSING MEDICATIONS. KITS SHOULD NOT BE SOLD IF NOT COMPLETE. THIS COULD CREATE A SERIOUS SITUATION. EMERGENCY MEDICATION KIT SHIPPED MISSING 7 LISTED MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244615 BANYAN STAT KIT BANYAN STAT KIT LRR BANYAN INTERNATIONAL CORP. 32630

    Patients

    Seq Age Sex Outcome Treatment
    1 Other