BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O.B. ULTRA NON-APPLICATOR 40S

    MDR report key: 2015980 · Received February 25, 2011

    Report

    Report Number
    8022269-2011-00005
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    PMA / PMN Number
    K990536
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL REVIEW IDENTIFIED THAT A CORRECTION WAS REQUIRED TO A PREVIOUSLY SUBMITTED REPORT. IN ADDITION THE RESULTS OF A VISULA INSPECTION AND A QUALITY INVESTIGATION REVEALED THAT TEST RESULTS MEET SPECIFICATIONS ON THE RETURNED SAMPLE AND THERE WERE NO TRENDS OBSERVED. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    DATE OF THIS SUBMISSION IS (B)(4) 2011. THIS CLOSES OUT THIS REPORT UNLESS OTHER SIGNIFICANT INFO IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011, FROM A (B)(6) FEMALE CONSUMER REPORTING ON SELF FROM (B)(6). THE CONSUMER DID NOT HAVE ANY KNOWN MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2011, THE CONSUMER STARTED USING O.B. ULTRA ABSORBENCY TAMPONS, ONE TIME VAGINALLY DURING PERIODS FOR NORMAL MENSTRUATION (LOT NUMBER 0200M6973, EXPIRATION DATE UNSPECIFIED). ON THE SAME DAY, WHEN SHE TRIED TO REMOVE THE TAMPON, THE STRING BROKE OFF AND THE TAMPON GOT STUCK IN HER VAGINA. SHE VISITED THE EMERGENCY ROOM TO GET THE TAMPON REMOVED. ON THE SAME DAY, THE DEVICE WAS DISCONTINUED AND THE EVENT RESOLVED. THIS REPORT WAS ASSESSED AS SERIOUS EVENT. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT IS ALSO CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    CONSUMER REPORTS THAT TAMPON GOT STUCK IN VAGINA DUE TO STRING BREAKING. SHE WENT TO THE EMERGENCY ROOM AND HAD IT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O.B. ULTRA NON-APPLICATOR 40S TAMON HEB MONTREAL SAN PRO 8004170200 0200M6973

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| O| R