BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C8402, M ALEXIS O WND PROT/RET 5/BX

    MDR report key: 6998226 · Received November 2, 2017

    Report

    Report Number
    2027111-2017-02100
    Event Type
    Injury
    Date Received
    November 2, 2017
    Report Date
    November 22, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT # HAS BEEN PROVIDED TO MANUFACTURER. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS A RESULT, THE COMPLAINANT'S EXPERIENCE COULD NOT BE CONFIRMED. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE EVENT. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND RELATED PRODUCT. AT THIS TIME, APPLIED MEDICAL IS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. ALTHOUGH THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONFIRMED, APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: "HALS PROCEDURE". EVENT DESCRIPTION: "SURGEON WAS DOING A HALS PROCEDURE WITH GELPORT AND AFTER THE PROCEDURE WAS OVER THE INNER GREEN RING WAS LEFT INSIDE OF THE PATIENT WHICH WAS NOT DISCOVERED UNTIL 8 YEARS LATER." ADDITIONAL INFORMATION WAS RECEIVED VIA TELEPHONE FROM TERRITORY MANAGER ON FRIDAY (B)(6) 2017: " I HAVE NO INFORMATION ON THIS SITUATION. I DON'T KNOW THE LOT # OR THE INSTITUTION OF WHERE IT HAPPENED. IT HAPPENED SOMEWHERE IN NASHVILLE, TN. I DON'T KNOW WHEN THIS EVENT OCCURRED. I REALLY HAVE NO INFORMATION AT ALL" TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777064 C8402, M ALEXIS O WND PROT/RET 5/BX KGW KGW APPLIED MEDICAL RESOURCES C8402 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other