BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B. UNSPECIFIED CA

    MDR report key: 2172213 · Received June 15, 2011

    Report

    Report Number
    8022269-2011-00018
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CLOSES OUT THIS REPORT UNLESS ADD'L SIGNIFICANT INFO IS RECEIVED.

    Description of Event or Problem · 1

    CONSUMER REPORTS THAT 2 STRINGS BROKE FROM HER BOX OF TAMPONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O.B. UNSPECIFIED CA TAMPON HEB MONTREAL SAN PRO OBGENCA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other