BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 7003231 · Received November 6, 2017

    Report

    Report Number
    2936999-2017-05599
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 31, 2017
    Report Date
    January 31, 2018
    Manufacturer
    MMJ SA DE CV (USD)
    Product Code
    BTQ
    PMA / PMN Number
    K760125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: REPORT 2936999-2017-05599 WAS NOT REQUIRED TO BE SUBMITTED. CORRECTED FIELDS: UPON FURTHER EVALUATION, THIS IS NOT A REPORTABLE EVENT. THERE WAS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. IT IS NOTED THAT THE PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BE OBTAINED, IT WILL BE PROVIDED AND UPDATED IN A SUPPLEMENTAL REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT THE ITEM WAS SEALED IN THE BOX AND THE PACKAGE WAS SEALED BUT THERE WAS NO PRODUCT IN IT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781894 MALLINCKRODT AIRWAY, NASOPHARYNGEAL BTQ MMJ SA DE CV (USD) 8888247031 17H0574JZX

    Patients

    Seq Age Sex Outcome Treatment
    1