BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B. ULTRA ABSORBENCY TAMPONS

    MDR report key: 2895891 · Received January 4, 2013

    Report

    Report Number
    8022269-2013-00002
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 9, 2012
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    PMA / PMN Number
    K990536
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    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 O.B. ULTRA ABSORBENCY TAMPONS FOR MENSTRUATION (ROUTE-VAGINAL, EXPIRATION DATE 28-FEB-2015, LOT NUMBER AND FREQUENCY UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE NOTICED THAT THE STRINGS BROKE OFF FROM MAJORITY OF THE TAMPONS IN BOTH THE BOXES, SHE HAD PURCHASED. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. CONCLUSION FROM QUALITY INVESTIGATION ON (B)(4) 2012: NO PRODUCT WAS RETURNED AND NO VALID LOT NUMBER WAS PROVIDED. A REVIEW OF THE DATA ASSOCIATED WITH THE STRING ISSUE FOUND NO ADVERSE TREND ON THE O.B. ULTRA FAMILY. DUE TO LACK OF A COMPLAINT SAMPLE AND THE ABSENCE OF ADVERSE TREND, THERE WAS NO EVIDENCE TO CONFIRM THAT THE DEVICE FAILED TO MEET THE SPECIFICATIONS. COMPLAINT TRENDS WOULD 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
    4257 O.B. ULTRA ABSORBENCY TAMPONS TAMPON HEB MONTREAL SAN PRO 8004170200 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1