BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B. PROCOMFORT DIGITAL SUPER

    MDR report key: 2614333 · Received June 12, 2012

    Report

    Report Number
    8022269-2012-00038
    Event Type
    Malfunction
    Date Received
    June 12, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 2, 2012
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    PMA / PMN Number
    K974629
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPONSOR HAS SELF-IDENTIFIED CHANGES REQUIRED TO ITS STANDARD OPERATING PROCEDURES FOR MDR REPORTING AND THESE EVENTS ARE BEING REPORTED IN ACCORDANCE WITH THE NEW SOP. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A (B)(6) OLD FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM CANADA. THE MEDICAL HISTORY INCLUDED CROHNS DISEASE AND ALLERGY TO NUTS. THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O.B TAMPONS PROCOMFORT SUPER, FOUR TO SIX TAMPONS A DAY, VAGINALLY FOR MENSTRUATION (LOT NUMBER, EXPIRATION DATE, DOSE AND FREQUENCY UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, ON (B)(6) 2012, SHE NOTICED ON THREE OCCASIONS THAT THE TAMPON MATERIAL RIPPED OUT OF THE TAMPONS AND GOT STUCK IN HER BODY. SHE CONTACTED HER HEALTHCARE PROFESSIONAL TO CHECK WHETHER THE PIECE OF TAMPON CAME OUT OR WAS STILL STUCK INSIDE. ON (B)(6) 2012, SHE DISCONTINUED THE USE OF THE TAMPON AND THE EVENT RESOLVED ON THE SAME DAY. THE REPORT WAS ASSESSED AS NON-SERIOUS EVENT AND THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. DUE TO THE UNAVAILABILITY OF THE SAMPLE, IT IS NOT POSSIBLE TO EVALUATE THE PARTICULAR ALLEGED DEFECT. NO LOT NUMBER WAS PROVIDED WITH THE COMPLAINT. WITHOUT A VALID LOT NUMBER, THE DEVICE HISTORY RECORD AND LOT TRENDING CANNOT BE REVIEWED. A REVIEW OF THE DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY REVEALED NO ADVERSE TRENDS. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O.B. PROCOMFORT DIGITAL SUPER TAMPON HEB MONTREAL SAN PRO OBDPCSCA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR