BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B. SUPER PLUS NON-APPLICATOR

    MDR report key: 2193438 · Received July 13, 2011

    Report

    Report Number
    8022269-2011-00020
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Report Date
    June 18, 2011
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    PMA / PMN Number
    K974629
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(4) 2012. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED. THIS REPORT IS BEING SUBMITTED TO CORRECT THE INITIAL PREVIOUSLY SUBMITTED REPORT ON (B)(4) 2011. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    DATE OF THIS SUBMISSION IS JULY 13, 2011. THIS CLOSES OUT THIS REPORT UNLESS ADD'L SIGNIFICANT INFO IS RECEIVED.

    Description of Event or Problem · 1

    CONSUMER REPORTS THAT UPON OPENING THE BOX OF TAMPONS, THEY WERE NOT WRAPPED IN PLASTIC, AND THERE WERE NOT STRINGS ATTACHED TO THE TAMPONS. INITIAL SUBMITTED REPORT IS BEING RE-SUBMITTED TO CORRECT THE J&J AWARENESS DATE. THE AWARENESS DATE WAS UPDATED FROM (B)(6) 2011. THE REPORT REMAINS A REPORTABLE MALFUNCTION CASE.

    Description of Event or Problem · 1

    CONSUMER REPORTS THAT UPON OPENING THE BOX OF TAMPONS, THEY WERE NOT WRAPPED IN PLASTIC, AND THERE WERE NOT STRINGS ATTACHED TO THE TAMPONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O.B. SUPER PLUS NON-APPLICATOR TAMPON HEB MONTREAL SAN PRO 8004134500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention