BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C8301, S ALEXIS WND PROT/RET 5/BX

    MDR report key: 6213600 · Received December 29, 2016

    Report

    Report Number
    2027111-2016-00926
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    August 8, 2016
    Report Date
    April 25, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    UDI-DI
    00607915117207
    PMA / PMN Number
    K041711
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE EVENT. 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.

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED UNKNOWN - "ALEXIS WAS TORN DURING USE." PATIENT STATUS: "THERE WAS NO SPECIAL EVENT OR RESULT TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864511 C8301, S ALEXIS WND PROT/RET 5/BX KGW KGW APPLIED MEDICAL RESOURCES C8301 1254308 00607915117207

    Patients

    Seq Age Sex Outcome Treatment
    1