BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B. MULTIPACK

    MDR report key: 2884760 · Received December 26, 2012

    Report

    Report Number
    8022269-2012-00161
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Report Date
    December 16, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(4) 2013. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING OB COMBINATION PACKS, VAGINALLY FOR MENSTRUATION (LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE STRING BROKE WHILE ATTEMPTING TO REMOVE THE TAMPON. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012, FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O.B. COMBINATION PACKS, VAGINALLY FOR MENSTRUATION (LOT NUMBER, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE STRING BROKE WHILE ATTEMPTING TO REMOVE THE TAMPON. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 NO VALID LOT NUMBER PROVIDED AND NO SAMPLE WAS RETURNED. BASED ON LACK OF COMPLAINT SAMPLE AND ABSENCE OF TRENDS, THERE IS NO EVIDENCE TO CONFIRM THAT THE DEVICE FAILED TO MEET THE SPECIFICATIONS. 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. MULTIPACK TAMPON HEB MONTREAL SAN PRO OBREZUUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1