BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUANG INNER EAR SHUNT / ELS SHUNT

    MDR report key: 10471684 · Received August 28, 2020

    Report

    Report Number
    MW5096332
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Report Date
    August 26, 2020
    Manufacturer
    E. BENSON HOOD LABORATORIES, INC.
    Product Code
    ESZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HUANG INNER EAR SHUNT COMES IN A WHITE PEEL PACK THAT LOOKS STERILE AND DOES NOT SAY NON STERILE. IT ONLY SAYS NON STERILE ON THE BOX. THE STERILIZATION INSTRUCTIONS ARE VAGUE AND CONFUSING. WE CONTACTED THE MANUFACTURER FOR UPDATED STERILIZATION INSTRUCTIONS. THEY TELL YOU TO STERILIZE IN THE PEEL PACK, HOWEVER THERE IS NO INDICATOR IN THE PEEL PACK. THEY DO NOT TELL YOU HOW LONG TO DRY. I AM ATTACHING THE INSTRUCTIONS THAT CAME IN THE BOX AND THE UPDATED INSTRUCTIONS SENT FROM THE MANUFACTURER. WE ARE CONCERNED WITH THE SAFETY OF PACKAGING AND THE STERILIZATION INSTRUCTIONS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933587 HUANG INNER EAR SHUNT / ELS SHUNT TUBE, SHUNT, ENDOLYMPHATIC ESZ E. BENSON HOOD LABORATORIES, INC. GS-2000

    Patients

    Seq Age Sex Outcome Treatment
    1