BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B. UNSPECIFIED

    MDR report key: 2094159 · Received April 19, 2011

    Report

    Report Number
    8022269-2011-00012
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Report Date
    March 30, 2011
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT IS 04/19/2011. THIS CLOSES OUT THIS REPORT UNLESS SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    CONSUMER REPORTS THAT THE STRINGS ON THE TAMPON WERE FALLING OFF UPON TRYING TO REMOVE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O.B. UNSPECIFIED NONE HEB MONTREAL SAN PRO

    Patients

    Seq Age Sex Outcome Treatment
    1