BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O.B. UNSPECIFIED

    MDR report key: 1970447 · Received January 20, 2011

    Report

    Report Number
    8022269-2011-00003
    Event Type
    Injury
    Date Received
    January 20, 2011
    Report Date
    January 13, 2011
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    PMA / PMN Number
    K974629
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THIS SUBMISSION IS (B)(4), 2011. THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL SIGNIFICANT INFO IS RECEIVED.

    Description of Event or Problem · 1

    CONSUMER INSERTED A TAMPON AND UPON TRYING TO REMOVE THE STRING BROKE. SHE WENT TO THE EMERGENCY ROOM AND HAD THE TAMPON REMOVED. UPON INSERTION OF ANOTHER TAMPON, THE STRING BROKE AND SHE HAD TO RETURN TO THE EMERGENCY ROOM FOR REMOVAL OF THE TAMPON.

    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 Other| R