BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 4080746 · Received September 10, 2014

    Report

    Report Number
    2183446-2014-00001
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MEDOVATIONS
    Product Code
    FAT
    PMA / PMN Number
    K972119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL WAS UNABLE TO PROVIDE EXACT PART NUMBER AND LOT NUMBER OF 24FR BOUGIE AND PART WAS NOT RETURNED FOR EVAL. A REVIEW OF SHIPMENT RECORDS TO THIS CUSTOMER SHOWS THE LIKELY DEVICE TO BE PART NUMBER 1208-24 AND LOT NUMBER 212841, SHIPPED ON (B)(4) 2012. THE BOUGIES ARE A REUSABLE DEVICES, LABELED WITH A 3 YEAR EXPIRATION DATE. PT ESOPHAGEAL PERFORATION WAS REPAIRED WITH 4 SUTURES DURING OPEN APPROACH OF HERNIA REPAIR PROCEDURE. PT DID NOT RECEIVE ANY ADDITIONAL TREATMENT. THERE WAS NO MALFUNCTION OF THE DEVICE AND THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE INJURY.

    Description of Event or Problem · 1

    PT UNDERWENT REPAIR OF A LARGE INCARCERATED PARAESOPHAGEAL HERNIA. WHILE PASSING 24F BOUGIE DOWN ESOPHAGUS, A PERFORATION WAS NOTED. PROCEDURE WAS CONVERTED FROM LAPAROSCOPIC TO OPEN APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558019 NI BOUGIE FAT MEDOVATIONS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R