BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIGRAFT

    MDR report key: 12494754 · Received September 20, 2021

    Report

    Report Number
    12494754
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    August 5, 2021
    Report Date
    September 10, 2021
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    MDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OUTER EXPIRATION DATE ON THE INTEGRA LIFESCIENCES CORPORATION OMNIGRAFT DID NOT MATCH THE EXPIRATION DATE ON THE INSIDE PACKAGE. MANUFACTURER'S RECOMMENDATION CONFLICTS WITH OUR REGULATORY AGENCY WHICH RECOMMENDS THE INNER PACKAGE DATE CLOSEST TO THE ITEM TO BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394720 OMNIGRAFT DEVICE, DERMAL REPLACEMENT MDD INTEGRA LIFESCIENCES CORPORATION 5329553

    Patients

    Seq Age Sex Outcome Treatment
    1