BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B. ULTRA NON-APPLICATOR USA

    MDR report key: 2240847 · Received August 16, 2011

    Report

    Report Number
    8022269-2011-00024
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    August 2, 2011
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    PMA / PMN Number
    K990536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THIS SUBMISSION IS AUGUST 16, 2011. THIS CLOSES OUT THIS REPORT UNLESS ADD'L SIGNIFICANT INFO IS RECEIVED.

    Description of Event or Problem · 1

    CONSUMER REPORTS THAT THE STRING FELL OFF THE TAMPON AND SHE HAD A HARD TIME REMOVING THE TAMPON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O.B. ULTRA NON-APPLICATOR USA TAMPON HEB MONTREAL SAN PRO 8004170200 3539M6789

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention