BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2940599 · Received January 30, 2013

    Report

    Report Number
    2027111-2013-00025
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE ACKNOWLEDGING RECEIPT OF THIS CUSTOMER EXPERIENCE REPORT FROM (B)(6). THE CUSTOMER HAS BEEN CONTACTED FOR MORE DETAILS. AS OF NOW, WE HAVE NO MODEL OR LOT# TO PROVIDE. A FOLLOW-UP REPORT WILL BE PROVIDED UPON INFORMATION BECOME AVAILABLE FOR INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOW OR WADS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    "INJURY SUSTAINED ON PT, ONE BOWEL PERFORATION. THE INCIDENT IS CURRENTLY BEING INVESTIGATED INTERNALLY TO ESTABLISH THE EXACT CAUSE OF THE INJURY. HOSPITAL NOT ABLE TO GIVE ANY FURTHER DETAILS AT THIS TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40470 NONE GCJ APPLIED MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other