BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14MM ADAPTOR

    MDR report key: 2321306 · Received October 28, 2011

    Report

    Report Number
    MW5022906
    Event Type
    Malfunction
    Date Received
    October 28, 2011
    Report Date
    October 28, 2011
    Manufacturer
    GYRUS ACMI, GYN
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DEVICE BEING SOLD NON-STERILE TO HOSPITALS WITH NO INSTRUCTIONS FOR STERILIZATION. PRODUCT (B)(4) 14MM ADAPTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 14MM ADAPTOR 14MM ADAPTOR HIH GYRUS ACMI, GYN 003693

    Patients

    Seq Age Sex Outcome Treatment
    1