BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT HS GEL PAD LEFT SIDE

    MDR report key: 933937 · Received October 26, 2007

    Report

    Report Number
    3004608878-2007-00028
    Event Type
    Malfunction
    Date Received
    October 26, 2007
    Report Date
    October 26, 2007
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INCIDENT. CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORP.

    Description of Event or Problem · 1

    INTEGRA RECEIVED AN ADVERSE INCIDENT REPORT FROM MEDICINES AND HEALTHCARE PRODUCT REGULATORY AGENCY (MHRA) IN 2007, ADVISING OF THE FOLLOWING INCIDENT: TWO CLIPS FROM THE DEVICE BROKE AND THE PAD BECAME UNATTACHED FROM THE HEADREST LEAVING THE PT'S HEAD ON THE METAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT HS GEL PAD LEFT SIDE HORESHOE HEADREST HBL INTEGRA LIFESCIENCES CORPORATION 041

    Patients

    Seq Age Sex Outcome Treatment
    1 YR