BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 7850574 · Received September 6, 2018

    Report

    Report Number
    8020889-2018-00082
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    August 1, 2018
    Report Date
    November 2, 2018
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS REPORT 8020889-2018-00082 WAS SENT IN ERROR AS A DUPLICATE FOR MFR REPORT NUMBER: 8020889-2018-00079, ANY ADDITIONAL INFORMATION RECEIVED IN THE FUTURE WILL BE CAPTURED AND SUBMITTED UNDER THE REPORT NUMBER 8020889-2018-00079. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD AN ELASTIC IN THE PACKAGING. THE CUSTOMER INDICATED NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692000 SHILEY JOH MALLINCKRODT MEDICAL 313880 201406078X

    Patients

    Seq Age Sex Outcome Treatment
    1