BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    86MM INSERT NON-STERILE

    MDR report key: 2013515 · Received February 3, 2011

    Report

    Report Number
    2027111-2011-00009
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 20, 2011
    Report Date
    February 3, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT NUMBER IS PROVIDED. A DEVICE HISTORY REPORT IS BEING REVIEWED BY ENGINEERING IN ORDER TO FURTHER INVESTIGATE THIS INCIDENT AND A FOLLOW-UP REPORT WILL BE SENT WITHIN 30 DAYS OR UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    "CUSTOMER STATES THE A0903 SETS ARE COMING UNDONE AND BREAKING DURING SURGERY. CUSTOMER (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 86MM INSERT NON-STERILE NONE GCJ APPLIED MEDICAL A0903 1119578

    Patients

    Seq Age Sex Outcome Treatment
    1